Atlas FDA

EBG

189 FDA 510(k) clearances · Product code

86 daysmedian time to decision
254 days90th percentile
189clearances measured

FDA profile

Official device name
Crown And Bridge, Temporary, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3770
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2008: 4 · 2012: 5 · 2013: 11 · 2014: 23 · 2015: 26 · 2016: 8
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
Dura-Arch (K261261)Hangzhou SHINING3D Dental Technology Co., Ltd.2026-04-17
“FLNT Base” and “FLNT Temp” (K253380)Liaoning Upcera Co., Ltd.2026-03-02
TempFIT Temporary Crown and Bridge Resin (K251271)Rizhao Huge Biomaterials Company, Ltd.2025-06-23
DentaTOOTH (K243370)Asiga Pty, Ltd.2025-05-05
Evoblock, Perléon (K243621)Evoden Indústria Comércio Importação E Exportação2025-04-22
TEMP MASTER, PMMA-based dental resin (K243951)Taiwan Dental Materials Co., Ltd.2025-02-21
PrimmaArt (K231859)Dentscare Ltda2024-11-26
Digital Temp (K242559)Sprintray, Inc.2024-11-26
Premium Teeth Resin (K240538)Formlabs Ohio, Inc.2024-07-19
Fixtemp® C&B 4:1 (K241226)Dreve Denatmid GmbH2024-05-31
dima Print Teeth & Temp (K233868)Kulzer, LLC2024-05-23
PMMA BLOCK (K223706)Huliang(Shanghai) Bio-Tech Co., Ltd.2023-05-12
PMMA Blocks for Dental Use (K223477)Aidite (Qinhuangdao) Technology Co., Ltd.2023-02-16
CURA-Temp (K202965)Mgnewton , Ltd.2022-12-21
Hexa-Temp (K214071)Spident Co., Ltd.2022-03-10
UltraPrint-Dental Temp C&B UV (K213643)Guangzhou Heygears IMC., Inc.2022-01-14
C&B 5.0 Hybrid (K210817)Arum Dentistry Co., Ltd.2021-12-08
E-Temp (K211101)Envisiontec GmbH2021-06-14
PuRE PMMA Disc (K201563)Quest Dental USA Corp.2021-04-09
Aidite PMMA (K190217)Aidite (Qinhuangdao) Technology Co., Ltd.2020-12-17
GR-17 Resin System (K201827)Pro3Dure Medical GmbH2020-11-05
PMMA Block (K201683)Huge Dental Material Co., Ltd.2020-11-03
FREEPRINT temp (K200273)Detax GmbH & Co. KG2020-10-27
Structur CAD (K201090)Voco GmbH2020-09-09
Bright Temporary C&B (K192830)Dmp Dental Industry S.A.2020-09-02
P pro Crown & Bridge (K200039)Deltamed GmbH2020-07-31
GC Temp Print (K193113)GC America, Inc.2020-07-09
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA (K200676)Zirkonzahn Srl2020-07-08
VarseoSmile Temp (K193553)Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG2020-05-18
AA temp temporary restoration 3D printing photoreactive resin (K191590)Enlighten Materials Co., Ltd.2020-05-05
DiaTemp Flow (K192022)DiaDent Group International2020-02-13
DiaTemp (K192158)DiaDent Group International2020-02-13
DENTCA Crown and Bridge (K192806)Dentca, Inc.2020-02-05
Portux CAD/CAM Disc (K192153)New Stetic, SA2019-11-07
Ceramill A-Temp (K191843)Amann Girrbach AG2019-10-04
TurboTemp EZ (K191619)Zest Anchors, LLC2019-09-11
SmarTemp X1 (K190930)Parkell, Inc.2019-09-05
MD-Temp Plus (K190724)Meta Biomed Co., Ltd.2019-07-03
LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 (K183337)DMG Chemisch-Pharmazeutische Fabrik GmbH2019-05-29
EVOLUX CAD/CAM PMMA BLOCKS (K182065)Blue Dent Dental2018-12-13
Harvest Dental Polymer Blocks (K180578)Harvest Dental Products, LLC2018-12-12
Resin for Temporary Crown & Bridge (K180657)Dentis Co., Ltd.2018-12-07
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT (K180562)Zirkonzahn GmbH2018-06-28
Fixtemp C&B (K171729)Dreve Dentamid GmbH2017-12-13
PuRE PMMA Disc (K172281)Quest Dental USA Corp.2017-10-19
DD medical polymers (K153490)Dental Direkt GmbH2016-05-13
Vericore Gradient Temporary Disc (K152443)Whip Mix Corporation2016-05-11
TelioCAD Multi (K153753)Ivoclar Vivadent, Inc.2016-04-12
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR (K152215)Dentalplus GmbH2016-01-19
YAMAHACHI PMMA DISKS (K151764)Yamahachi Dental Products USA, Inc.2015-11-23
SuPro 100 (K151144)3M Deutschland GmbH2015-09-14
IDODENTINE DISC, IDODENTINE BLOCK (K150432)Union Dental S.A.2015-08-14
Luminesse PMMA (K142371)Talladium, Inc.2015-04-24
TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS (K133268)Schutz-Dental GmbH2015-02-12
PMMA BLOCK (K141421)Rizhao Huge Dental Industry Co., Ltd.2015-02-09
MSN-006 (K141562)GC America, Inc.2014-09-05
ARGEN PMMA (K140894)The Argen Corporation2014-07-31
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) (K132937)Harvest Dental Products, LLC2014-05-21
COPRA TEMP PMMA-DISK (K131664)White Peaks Dental Systems GmbH & Co. KG2013-12-18
PEKKTON IVORY (K123638)Cendres & Metaux SA2013-02-21
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B (K122039)Kettenbach GmbH & Co. KG2012-12-27
BRIGHTGLASS BRIGHTGLASS M (K122025)Ktk Medical Supplies GmbH2012-10-09
PMMA CAD/CAM DISC (K112967)Polident D.O.O., Dental Products Industry2012-08-28
TUFF-TEMP 2.0 (K120784)Pulpdent Corporation2012-06-08
STRUCTUR 3 (K120779)Voco GmbH2012-06-01
FIBER DISK AND BLOCK (K112186)Bioloren S.R.L.2011-11-08
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN (K111666)Neodental Chemical Products Co., Ltd.2011-09-07
FIXTEMP C&B (K102917)Exacta Dental Direct, Inc.2011-06-17
TEMPFLEX (K110747)Kerr Corporation2011-06-14
PRO-V COAT (K103514)Bisco, Inc.2011-05-25
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL (K110484)Novocol, Inc.2011-05-17
EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM (K102776)Deltamed GmbH2011-02-18
TELIO CS INLAY & TELIO CS ONLAY (K103379)Ivoclar Vivadent, Inc.2011-02-14
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) (K103474)Micerium S.P.A.2011-02-07
TURBO TEMP 3 (K102753)Danville Materials, Inc.2011-02-04
VIPI BLOCK (K102341)Vipi Industria,Comercio,Exportacao E Importacao DE2010-12-16
LUXATEMP ULTRA /STAR (K101710)Dmg USA, Inc.2010-09-28
DIRECT CROWN NATURAL 1 (K101814)Candulor USA, Inc.2010-09-27
TELIO CAD (K093708)Ivoclar Vivadent, Inc.2010-03-10
MIZZY EXPRESS (K093380)Mycone Dental Supply Co., Inc.2010-03-05
TEMPORARY C&B COMPOSITE (K091894)Voco GmbH2009-07-23
MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN (K083195)Lang Dental Mfg. Co., Inc.2009-06-05
TEMPORARY COLD.V AND SELF-CURE DENTINE (K082700)Major Prodotti Dentari S.P.A.2008-12-09
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL (K081810)Pulpdent Corporation2008-09-17
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN (K081705)Lang Dental Mfg. Co., Inc.2008-09-17
ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES (K080556)Merz Dental GmbH2008-05-02
MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM (K080311)Dentsply Interntional2008-04-18
UNIFAST III (K073106)GC America, Inc.2008-04-11
ZENO PMMA DISC (K080182)Wieland Dental + Technik GmbH & Co. KG2008-04-08
PRO-V (K073263)Bisco, Inc.2008-02-14
TEMPXN28 (K073296)3M Espe AG Dental Products2008-01-09
WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED (K071548)Merz Dental GmbH2007-08-21
VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 (K070991)Vita2007-06-01
KAVO EVEREST C-TEMP (K063624)Kavo America2007-02-08
ARTEGRAL IMCROWN (K061809)Merz Dental GmbH2006-09-13
MD-TEMP (K061530)Meta Biomed Co., Ltd.2006-07-21
TEMPFX ESTHETIC PROVISIONAL SYSTEM (K061264)Dentsply International, Inc.2006-05-23
TEMPORARY CROWN & BRIDGE RESIN (K060881)Cosmedent, Inc.2006-05-16
PROVISIONAL INLAY/ONLAY KIT (K052800)Dmg USA, Inc.2006-03-07
TEMPORARY CROWN AND BRIDGE MATERIAL (K060293)Dentsply International, Inc.2006-02-17
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