510(k) K103474
- Device
- ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
- Applicant
- MICERIUM S.P.A.
- 510(k) number
- K103474
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-02-07
- Date received
- 2010-11-26
- Regulation
- 872.3770
- Classification name
- Crown And Bridge, Temporary, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SSA CARLA TAZZER
- Address
- Via Marconi 83 Avegno, Genoa IT 16030 16030
FDA Registration Numbers#
- 3012421607
- 3005665377
- 2183301
- 3011649314
- 9680845
- 1219645
- 9681356
- 3035693034
- 3011824442
- 3003310824
- 3007210751
- 8030452
- 3008912871
- 3005942449
- 9610902
- 2022039
- 3007031098
- 3024185724
- 3018507299
- 2087259
- 3020841418
- 3005904906
- 9612300
- 3002789526
- 3009727738
- 3017374693
- 2018957
- 1223843
- 3004966444
- 3010664129
- 3017674095
- 1420089
- 3030515618
- 3038718579
- 3008922120
- 2436986
- 1000492377
- 2023950
- 3009432160
- 9681199
- 9616065
- 3015525101
- 2921595
- 3011511773
- 3014270094
- 3024749697
- 3003120666
- 3010279788
- 3020093493
- 9681210
- 3009496224
- 1450653
- 2244842
- 3021381014
- 3014289665
- 8010711
- 3035335007
- 9615399
- 1000486347
- 3032163716
- 9680144
- 3004425647
- 3004967419
- 3010002722
- 1215305
- 3003756493
- 3008582406
- 3022545323
- 1036212
- 9616128
- 3043226252
- 3007740664
- 8010908
- 3008347275
- 3012389497
- 2081055
- 3007791519
- 3013551048
- 3006694515
Source Documents#
Other 510(k) Records For Product Code EBG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 |
| K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025-05-05 |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024-05-31 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 |
| K202965 | CURA-Temp | Mgnewton , Ltd. | 2022-12-21 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 |
Legacy Summary#
summary
FDA Review#
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