Atlas FDA

Dental

314 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
Straumann Emdogain (P930021/S034)The Straumann Company2025-09-05
TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System (P980052/S016)Stryker Leibinger, GmbH & Co KG2025-07-23
BIORA EMDOGAIN(R) (P930021/S033)The Straumann Company2025-06-10
INFUSE® Bone Graft (P050053/S065)Medtronic, Inc.2025-03-19
CALCIVIS Imaging System (P170029/S004)Calcivis Limited2025-03-03
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S095)Integra Lifesciences Corp.2025-02-18
CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S094)Integra Lifesciences Corp.2025-01-14
GEM 21S (P040013/S032)Lynch Biologics, LLC2024-11-22
INFUSE™ Bone Graft (P050053/S064)Medtronic, Inc.2024-11-06
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S093)Integra Lifesciences Corp.2024-08-29
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S015)Stryker Leibinger, GmbH & Co KG2024-08-08
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S014)Stryker Leibinger, GmbH & Co KG2024-07-30
CollaCote®, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S092)Integra Lifesciences Corp.2024-07-24
GEM 21S (GROWTH-FACTOR ENHANCED MATRIX (P040013/S031)Lynch Biologics, LLC2024-03-22
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S091)Integra Lifesciences Corp.2024-02-21
GEM21S® Growth Factor Enhanced Matrix (P040013/S030)Lynch Biologics, LLC2024-02-14
GEM21S (P040013/S029)Lynch Biologics, LLC2024-01-04
CALCIVIS Imaging System (P170029/S002)Calcivis Limited2023-11-17
CALCIVIS Imaging System (P170029/S003)Calcivis Limited2023-10-13
INFUSE™ Bone Graft (P050053/S062)Medtronic, Inc.2023-10-06
TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st (P980052/S012)Stryker Leibinger, GmbH & Co KG2023-08-22
INFUSE™ Bone Graft (P050053/S060)Medtronic, Inc.2023-08-21
INFUSE™ Bone Graft (P050053/S061)Medtronic, Inc.2023-08-21
Straumann Emdogain (P930021/S032)The Straumann Company2023-06-21
GEM21S (P040013/S028)Lynch Biologics, LLC2023-05-31
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S089)Integra Lifesciences Corp.2023-05-11
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S090)Integra Lifesciences Corp.2023-05-10
GEM21S Growth Factor Enhanced Matrix (P040013/S027)Lynch Biologics, LLC2023-05-04
Straumann Emdogain (P930021/S031)The Straumann Company2023-04-18
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S088)Integra Lifesciences Corp.2023-04-18
Straumann Emdogain (P930021/S028)The Straumann Company2023-04-04
Calcivis Imaging System (P170029/S001)Calcivis Limited2023-03-23
CALCIVIS Imaging System (P170029)Calcivis Limited2023-03-07
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings (P840062/S087)Integra Lifesciences Corp.2023-02-23
Straumann Emdogain (P930021/S030)The Straumann Company2023-02-03
Straumann® Emdogain® (P930021/S029)The Straumann Company2022-11-16
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S011)Stryker Leibinger, GmbH & Co KG2022-08-31
Infuse™ Bone Graft (P050053/S059)Medtronic, Inc.2022-08-09
CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S086)Integra Lifesciences Corp.2022-07-06
Infuse Bone Graft (P050053/S058)Medtronic, Inc.2022-06-09
CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S085)Integra Lifesciences Corp.2022-05-20
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S084)Integra Lifesciences Corp.2022-04-28
INFUSE™ Bone Graft (P050053/S057)Medtronic, Inc.2022-02-18
Infuse Bone Graft (P050053/S053)Medtronic, Inc.2022-02-18
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S082)Integra Lifesciences Corp.2021-11-13
Infuse Bone Graft (P050053/S051)Medtronic, Inc.2021-11-08
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S081)Integra Lifesciences Corp.2021-10-07
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S080)Integra Lifesciences Corp.2021-09-07
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S083)Integra Lifesciences Corp.2021-08-12
Patient-Fitted TMJ Reconstruction Prosthesis System (P980052/S009)Stryker Leibinger, GmbH & Co KG2021-04-27
INFUSE Bone Graft (P050053/S056)Medtronic, Inc.2021-04-06
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S079)Integra Lifesciences Corp.2021-02-26
Straumann Emdogain (P930021/S027)The Straumann Company2021-02-22
Infuse Bone Graft (P050053/S055)Medtronic, Inc.2021-02-08
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery (P840062/S078)Integra Lifesciences Corp.2021-01-19
GEM 21S Growth Factor Enhanced Matrix (P040013/S025)Lynch Biologics, LLC2021-01-15
Infuse Bone Graft (P050053/S052)Medtronic, Inc.2021-01-05
GEM21S Growth Factor Enhanced Matrix (P040013/S024)Lynch Biologics, LLC2020-12-04
Patient-Fitted TMJ Reconstruction Prosthesis System (P980052/S008)Stryker Leibinger, GmbH & Co KG2020-11-24
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S077)Integra Lifesciences Corp.2020-11-18
Straumann Emdogain (P930021/S026)The Straumann Company2020-09-02
Infuse Bone Graft (P050053/S054)Medtronic, Inc.2020-08-27
Infuse Bone Graft (P050053/S050)Medtronic, Inc.2020-07-10
GEM215 Growth Factor Enhanced Matrix (P040013/S023)Lynch Biologics, LLC2020-06-17
Straumann Emdogain (P930021/S024)The Straumann Company2020-05-15
Infuse Bone Graft (P050053/S045)Medtronic, Inc.2020-02-05
Patient-Fitted TMJ Reconstruction Prosthesis System (P980052/S007)Stryker Leibinger, GmbH & Co KG2020-01-10
Total Temporomandibular Joint Replacement System (P020016/S011)Biomet Microfixation, Inc.2019-12-17
Infuse Bone Graft (P050053/S046)Medtronic, Inc.2019-12-16
INFUSE Bone Graft (P050053/S049)Medtronic, Inc.2019-12-04
INFUSE BONE GRAFT (P050053/S048)Medtronic, Inc.2019-11-29
INFUSE Bone Graft (P050053/S047)Medtronic, Inc.2019-11-01
Staumann Emdogain (P930021/S025)The Straumann Company2019-09-03
GEM21S Growth Factor Enhanced Matrix (P040013/S022)Lynch Biologics, LLC2019-08-19
Infuse Bone Graft (P050053/S044)Medtronic, Inc.2019-07-25
CollaCote, CollaTape, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S076)Integra Lifesciences Corp.2019-06-27
Straumann Emdogain (P930021/S023)The Straumann Company2019-06-21
CollaCote and CollaTape Absorbable Collagen Wond Dressing for Dental Surgery (P840062/S069)Integra Lifesciences Corp.2019-06-14
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S075)Integra Lifesciences Corp.2019-05-07
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S074)Integra Lifesciences Corp.2019-05-07
Straumann Emdogain (P930021/S022)The Straumann Company2019-04-26
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy (P840062/S073)Integra Lifesciences Corp.2019-04-26
Straumann Emdogain (P930021/S021)The Straumann Company2019-04-23
CollaCote(TM), CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S072)Integra Lifesciences Corp.2019-04-19
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S071)Integra Lifesciences Corp.2019-03-14
Absorbable Collagen Plug for Dental Surgery, Absorbable Collagen Tape for Dental Surgery (P840062/S068)Integra Lifesciences Corp.2019-02-22
Infuse Bone Graft (P050053/S043)Medtronic, Inc.2019-01-15
Infuse Bone Graft (P050053/S042)Medtronic, Inc.2018-11-09
CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery (P840062/S070)Integra Lifesciences Corp.2018-11-07
Straumann Emdogain (P930021/S018)The Straumann Company2018-09-28
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S067)Integra Lifesciences Corp.2018-08-30
INFUSE Bone Graft (P050053/S041)Medtronic, Inc.2018-08-27
Straumann Emdogain (P930021/S019)The Straumann Company2018-08-14
Straumann Emdogain (P930021/S020)The Straumann Company2018-07-09
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S063)Integra Lifesciences Corp.2018-07-03
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S066)Integra Lifesciences Corp.2018-05-16
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings (P840062/S065)Integra Lifesciences Corp.2018-04-25
CollaCote, Colla Tape, CollaPlug, Absorable Collagen Wound Dressing for Dental Surgery (P840062/S064)Integra Lifesciences Corp.2018-02-08
Infuse Bone Graft (P050053/S040)Boston Scientific Corp2017-12-13
Infuse Bone Graft (P050053/S039)Medtronic, Inc.2017-06-14
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Every clearance here is in the API, with alerts when new ones post.