510(k) K052189
- Device
- REVENEER CERAMIC REPAIR SYSTEM
- Applicant
- SCHUTZ-DENTAL GMBH
- 510(k) number
- K052189
- Product code
- KLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-17
- Date received
- 2005-08-11
- Regulation
- 872.3200
- Classification name
- Agent, Tooth Bonding, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL WIERZ
- Address
- Dieselstrasse 5-6 Rosbach DE D-61191 D-61191
FDA Registration Numbers#
- 3008005217
- 3003120666
- 1000272892
- 2022039
- 3013411964
- 1013257
- 8044164
- 3032027578
- 9614573
- 3012421607
- 9616128
- 8044038
- 3003621174
- 3043226252
- 1410097
- 3008524225
- 3011148229
- 2024312
- 2411797
- 9612352
- 1413399
- 3006316962
- 3002807420
- 3008254125
- 3014683120
- 9615399
- 3044819802
- 2244812
- 3014615644
- 3010664129
- 3008882689
- 2437780
- 3010131268
- 3012502601
- 2433629
- 9680144
- 3045891668
- 9613375
- 3013584861
- 3008966075
- 8010638
- 3005665377
- 3005974404
- 8030067
- 3010419931
- 3007210751
- 3004475754
- 1718476
- 3018283083
- 1413475
- 2515379
- 3002808149
- 8010711
- 2424472
- 2133714
- 1281412
- 1032227
- 3039433962
- 9681356
- 3004140838
- 1725006
- 3013508670
- 3032378317
- 1718912
- 3006223010
- 3012494290
- 2027375
- 3010002722
- 8010908
- 1450653
- 3013557697
- 3031841433
- 3004425647
- 9610902
- 3026400121
- 3032163716
- 3002807050
- 3005628474
- 2086043
- 2023950
Source Documents#
Other 510(k) Records For Product Code KLE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | 2026-04-10 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 |
| K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026-03-03 |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 |
| K252151 | els unibond | Saremco Dental AG | 2025-12-05 |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | 2025-11-06 |
| K251124 | G-Bond Universal | GC America, Inc. | 2025-10-02 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | 2024-11-01 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | 2024-10-02 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 |
Legacy Summary#
summary
FDA Review#
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