Atlas FDA

EIH

486 FDA 510(k) clearances · Product code

87 daysmedian time to decision
230 days90th percentile
486clearances measured

FDA profile

Official device name
Powder, Porcelain
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6660
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 2013: 6 · 2021: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Obsidian® Press Over Zirconia (K262239)Prismatik Dentalcraft, Inc.2026-07-30
Dental Zirconia Blank & Coloring Liquid (K261046)Hunan Qinghao Puzhong Technology Co., Ltd.2026-07-17
Dandy Ceramic Stain and Glaze (K262195)Zima International Inc., dba Dandy2026-06-30
Zolid Lunaris (K260918)Amann Girrbach AG2026-06-29
Rosetta SM, Rosetta SP (K260859)Hass Corp.2026-06-11
DCMhotbond zircon (K253191)Dental Creativ Management GmbH2026-05-21
Eternal Art Porcelain Powders (K260067)Shandong Huge Dental Material Corporation2026-04-09
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K260370)Bloomden Bioceramics (HuNan) Co., Ltd.2026-03-30
IPS e.max Zirconia (K253953)Ivoclar Vivadent, Inc.2026-03-10
BruxZir® Shaded 16 PLUS (K254283)Prismatik Dentalcraft, Inc.2026-01-30
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (K253973)Liaoning Upcera Co., Ltd.2026-01-09
Glass Ceramic (K252789)Shenzhen Xiangtong Co., Ltd.2025-12-08
BruxZir® NOW (K252446)Prismatik Dentalcraft, Inc.2025-09-03
DenMat Multilayered Zirconia Disc (K251593)Denmat Holding, LLC2025-08-25
ARENA Star, Galaxy Star (K250063)Arum Dentistry Co., Ltd.2025-07-10
Multi M Series (K250826)Dmax Co., Ltd.2025-06-12
zirkon; structure; LFU shades, stains and glazes (K251084)Estetic Ceram AG2025-06-05
CERABIEN MiLai (K250673)Kuraray Noritake Dental, Inc.2025-05-29
Biomic Color Opaque (K250534)Aidite (Qinhuangdao) Technology Co., Ltd.2025-05-20
ZircaGlow & ZircaGlow HT Zirconia (K250393)United Zirconia2025-05-12
Dental Zirconia Ceramic (K250811)Aidite (Qinhuangdao) Technology Co., Ltd.2025-04-11
Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (K250025)Aidite (Qinhuangdao) Technology Co., Ltd.2025-03-14
BruxZir® Esthetic NOW (K250223)Prismatik Dentalcraft, Inc.2025-02-25
VITA YZ Multi Translucent (K243940)Vita Zahnfabrik H.Rauter GmbH & Co.2025-02-21
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) (K242740)Liaoning Rachcera Material Technology Co., Ltd.2024-12-05
Estar-ZE (K242521)Osstem Implant Co., Ltd.2024-11-20
Dental Glass Ceramics Blocks (HT, LT, MT) (K242407)Hunan Vsmile Biotechnology Co., Ltd.2024-11-13
ArgenZ MTZ (K242458)Argen Corporation2024-10-24
CEREC Cercon 4D CAD/CAM Blocks (K242462)Dentsply Sirona2024-10-24
Dental porcelain powder (K242400)Yilink (Tianjin) Biotechnology Co., Ltd.2024-10-10
LUXEN 5G (K241151)Dentalmax Co., Ltd.2024-09-30
Copra Supreme (K233064)Whitepeaks Dental Solutions GmbH2024-09-18
DD Hybridlayer (multicolored zirconia) (K241579)Dental Direkt GmbH2024-09-06
Kingcera Dental Zirconia Blank (K241602)Hunan Qinghao Puzhong Technology Co., Ltd.2024-08-30
Cercon® yo ML (K241557)Dentsply Sirona2024-08-28
Dental Glass Ceramics Blocks (HT,LT,ST) (K241715)Aidite (Qinhuangdao) Technology Co., Ltd.2024-07-12
Zirconia Block (K241316)Hunan Hualian Special Ceramics Co., Ltd.2024-07-09
Copran Zri (K232952)Whitepeaks Dental Solutions GmbH2024-06-24
rainbow Paste Stain SE (K233885)Genoss Co., Ltd.2024-06-21
Copra Smile, Copra Supreme Hyperion (K233158)Whitepeaks Dental Solutions GmbH2024-06-20
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) (K240672)Zhejiang Zahndent Biotechnology Co., Ltd.2024-06-07
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) (K240912)Anhui Miisen Intelligence Technology Co., Ltd.2024-05-31
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) (K240772)Hunan Ceramaster Material Technology Co., Ltd.2024-05-20
BruxZir® Esthetic (K240882)Prismatik Dentalcraft, Inc.2024-05-01
UltraThineer Zirconia Slurry (5Y-B) (K240419)Boston Micro Fabrication2024-04-12
BruxZir® Radiant (K240574)Prismatik Dentalcraft, Inc.2024-03-20
Pre-Sintered Zirconia Coloring Liquid (K232682)Chengdu Besmile Medical Technology Co., Ltd.2024-03-19
Obsidian® NOW (K234014)Prismatik Dentalcraft, Inc.2024-02-27
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono (K232174)Genoss Co., Ltd.2024-02-23
Dental Glass Ceramics (K232673)Chengdu Besmile Medical Technology Co., Ltd.2024-01-23
Dental Porcelain Powder (K232676)Chengdu Besmile Medical Technology Co., Ltd.2024-01-23
Zirconia Block (K233125)Hangzhou Ivista Medical Devices Co., Ltd.2024-01-12
Dental Glass Ceramics (K233016)Shenzhen Yurucheng Dental Materials Co., Ltd.2023-12-21
Dental Glass Ceramics Blocks (K232438)Aibodent Biotechnology Co., Ltd.2023-12-01
Gradual Dental Zirconia Blank (K231687)Liaoning Upcera Co., Ltd.2023-09-07
Dental Lithium Disilicate Glass-Ceramic (K230487)Fuzhou Rick Brown Biomaterials Co., Ltd.2023-07-03
Easy On Universal Glaze & Stain (K231264)Doctus Global2023-06-30
Perfit CL (K223029)Vatech Mcis Co., Ltd.2023-06-20
BruxZir™ TintEFX Coloring Liquid (K231347)Prismatik Dentalcraft, Inc.2023-06-09
Harvest Conceal ZR Block Out (K222961)Harvest Dental Products, LLC2023-06-02
Soreal Press, Soreal CAD (K230259)Shenzhen Up3D Technology Co., Ltd.2023-05-25
BruxZir™ Incisal Coloring Liquid (K230262)Prismatik Dentalcraft, Inc.2023-05-16
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K230003)Topzir Biotech Co., Ltd.2023-03-31
XT Stain/Glaze (K223192)Shenzhen Xiangtong Co., Ltd.2023-03-27
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) (K223253)Arum Dentistry Co., Ltd.2023-02-27
Glass Ceramics (K222513)Yilink (Tianjin) Biotechnology Co., Ltd.2023-02-10
Glass Ceramic (K223194)Shenzhen Xiangtong Co., Ltd.2023-02-10
ICE Ceramics, ICE Stains, Fresco (K213722)Zirkonzahn Srl2022-12-14
Dental Zirconia Ceramic (K222626)Aidite (Qinhuangdao) Technology Co., Ltd.2022-12-06
Zirconia Block (K222520)Yilink (Tianjin) Biotechnology Co., Ltd.2022-11-14
Perfit FS Dental Zirconia Fully Sintered Block (K222686)Vatech Acucera, Inc.2022-10-06
Esthetic Colorant (K220369)Kuraray Noritake Dental, Inc.2022-09-23
BruxZir NOW (K220816)Prismatik Dentalcraft, Inc.2022-08-02
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K221242)Hunan Vsmile Biotechnology Co., Ltd.2022-07-29
KDF Zirconia Disc (K221429)Denken-Highdental Co., Ltd.2022-07-14
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K221051)Changsha Honchon Technology Co., Ltd.2022-07-08
Coloring Liquid (K220017)Dongguan Xiangtong Co., Ltd.2022-06-29
BruxZir Opaque Coloring Liquid (K220960)Prismatik Dentalcraft, Inc.2022-06-29
CERABIEN MiLai (K213147)Kuraray Noritake Dental, Inc.2022-03-28
Vintage Prime Press (K212939)Shofu Dental Corporation2022-03-18
Zirconia Dental Ceramics (K214005)Shenzhen Yurucheng Dental Materials Co., Ltd.2022-02-18
Dental Zirconia Pre-shaded Block (K214003)Shenzhen Yurucheng Dental Materials Co., Ltd.2022-02-18
Dental Zirconia Ceramic (K213570)Aidite (Qinhuangdao) Technology Co., Ltd.2022-01-07
LUXEN CL Dental Liquid (K212548)Dentalmax Co., Ltd.2021-12-06
BruxZir Esthetic (K213425)Prismatik Dentalcraft, Inc.2021-11-17
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212765)Bloomden Bioceramics (HuNan) Co., Ltd.2021-11-15
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212259)Zirdent New Material Co., Ltd.2021-11-12
INNI-CERA (K211308)Aon Co., Ltd.2021-10-04
Amber Mill Q Series & Amber Mill Direct Series (K202952)Hass Corp.2021-08-26
IPS e.max One (K211916)Ivoclar Vivadent, AG2021-08-20
1Derful HS, 1Derful HT (K210884)1derful, Inc.2021-07-27
Estar-Z (K210097)Osstem Implant Co., Ltd.2021-07-02
MAZIC Claro CAD and MAZIC Claro Press (K203672)Vericom Co., Ltd.2021-07-01
Perfit FS Dental Zirconia Fully Sintered Block (K203590)Vatech Acucera, Inc.2021-06-24
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank (K203499)Vatech Acucera, Inc.2021-04-05
Non-Sterile Zirconia Block (K201492)Bioden Co., Ltd.2021-03-10
Perfit ZR HT Dental Zirconia blank (K203351)Vatech Acucera, Inc.2021-03-08
GenesisZr 4Y+ (ST1100) Zirconia (K201915)United Dental Resources Corporation2021-02-23
GenesisZr UHT700 Zirconia (K201608)United Dental Resources Corporation2021-01-28
Dentsply Sirona Universal Spray Glazes (K202629)Dentsply Sirona2021-01-20
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