EBG · Class II · 21 CFR 872.3770

FDA Product Code EBG: Crown And Bridge, Temporary, Resin

Leading manufacturers include 3M Company, DiaDent Group International and Aidite (Qinhuangdao) Technology Co., Ltd..

189
Total
189
Cleared
118d
Avg days
1977
Since
Growing category - 9 submissions in the last 2 years vs 5 in the prior period
Review times increasing: avg 152d recently vs 116d historically

FDA 510(k) Cleared Crown And Bridge, Temporary, Resin Devices (Product Code EBG)

189 devices
1–24 of 189
Cleared Apr 17, 2026
Dura-Arch
K261261
Hangzhou SHINING3D Dental Technology Co., Ltd.
Dental · 1d
Cleared Mar 02, 2026
“FLNT Base” and “FLNT Temp”
K253380
Liaoning Upcera Co., Ltd.
Dental · 153d
Cleared Jun 23, 2025
TempFIT Temporary Crown and Bridge Resin
K251271
Rizhao Huge Biomaterials Company, Ltd.
Dental · 60d
Cleared May 05, 2025
DentaTOOTH
K243370
Asiga Pty, Ltd.
Dental · 187d
Cleared Apr 22, 2025
Evoblock, Perléon
K243621
Evoden Ind?stria Com?rcio Importa??o E Exporta??o
Dental · 151d
Cleared Feb 21, 2025
TEMP MASTER, PMMA-based dental resin
K243951
Taiwan Dental Materials Co., Ltd.
Dental · 60d
Cleared Nov 26, 2024
PrimmaArt
K231859
Dentscare Ltda
Dental · 522d
Cleared Nov 26, 2024
Digital Temp
K242559
Sprintray, Inc.
Dental · 90d
Cleared Jul 19, 2024
Premium Teeth Resin
K240538
Formlabs Ohio, Inc.
Dental · 144d
Cleared May 31, 2024
Fixtemp® C&B 4:1
K241226
Dreve Denatmid GmbH
Dental · 29d
Cleared May 23, 2024
dima Print Teeth & Temp
K233868
Kulzer, LLC
Dental · 169d
Cleared May 12, 2023
PMMA BLOCK
K223706
Huliang(Shanghai) Bio-Tech Co., Ltd.
Dental · 151d
Cleared Feb 16, 2023
PMMA Blocks for Dental Use
K223477
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 90d
Cleared Dec 21, 2022
CURA-Temp
K202965
Mgnewton , Ltd.
Dental · 812d
Cleared Mar 10, 2022
Hexa-Temp
K214071
Spident Co., Ltd.
Dental · 73d
Cleared Jan 14, 2022
UltraPrint-Dental Temp C&B UV
K213643
Guangzhou Heygears IMC., Inc.
Dental · 57d
Cleared Dec 08, 2021
C&B 5.0 Hybrid
K210817
Arum Dentistry Co., Ltd.
Dental · 265d
Cleared Jun 14, 2021
E-Temp
K211101
Envisiontec GmbH
Dental · 62d
Cleared Apr 09, 2021
PuRE PMMA Disc
K201563
Quest Dental USA Corp.
Dental · 303d
Cleared Dec 17, 2020
Aidite PMMA
K190217
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 682d
Cleared Nov 05, 2020
GR-17 Resin System
K201827
Pro3dure Medical GmbH
Dental · 126d
Cleared Nov 03, 2020
PMMA Block
K201683
Huge Dental Material Co., Ltd.
Dental · 134d
Cleared Oct 27, 2020
FREEPRINT temp
K200273
Detax GmbH & Co. KG
Dental · 266d
Cleared Sep 09, 2020
Structur CAD
K201090
Voco GmbH
Dental · 139d

About Product Code EBG - Regulatory Context

510(k) Submission Activity

189 total 510(k) submissions under product code EBG since 1977, with 189 receiving FDA clearance (average review time: 118 days).

Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EBG Product Code

Recent submissions under EBG have taken an average of 152 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.

EBG devices are reviewed by the Dental panel. Browse all Dental devices →