510(k) K020514
- Device
- PULPDENT GLAZE II
- Applicant
- PULPDENT CORPORATION
- 510(k) number
- K020514
- Product code
- KLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-16
- Date received
- 2002-02-15
- 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
- KENNETH J BERK
- Address
- 80 Oakland St. Watertown MA US 02472 02472
FDA Registration Numbers#
- 3038718579
- 3008882689
- 9611385
- 3004425647
- 3032378317
- 2523320
- 1215305
- 2024980
- 2244842
- 3018507299
- 3007584711
- 9680845
- 3005176727
- 3013584861
- 1000625496
- 8044038
- 8010711
- 2081055
- 2511556
- 8010638
- 2023950
- 1000118628
- 2411797
- 3008582054
- 3039433962
- 8010908
- 2027375
- 9615399
- 3017674095
- 3002789526
- 2429849
- 3002808149
- 1424442
- 1410097
- 3007210751
- 2437780
- 3002807050
- 3011649314
- 3003120666
- 1815540
- 3004475754
- 2022039
- 8044164
- 3011824442
- 3038295269
- 3014615644
- 3027616
- 9612300
- 3008912871
- 3043226252
- 1125730
- 3010131268
- 3000219976
- 3012477813
- 3010419931
- 3013411964
- 3035693034
- 3032312561
- 3012421607
- 3003621174
- 3018283083
- 3006694515
- 2424472
- 2126683
- 3010664129
- 1000272892
- 9613375
- 3005665377
- 2086043
- 3010002722
- 3026400121
- 3003449480
- 3008524225
- 2916735
- 1281412
- 3042272797
- 1718476
- 1718912
- 3027584973
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases