510(k) K030036
- Device
- TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
- Applicant
- Pulpdent Corporation
- 510(k) number
- K030036
- Product code
- DYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-12
- Date received
- 2003-01-03
- Regulation
- 872.3750
- Classification name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- KENNETH J BERK
- Address
- 80 Oakland St. Watertown MA US 02472 02472
FDA Registration Numbers#
- 1815540
- 3008882689
- 3038718579
- 3004130302
- 9613953
- 3012187973
- 3010032042
- 3032378317
- 3016543896
- 1215305
- 2024980
- 2024312
- 3007584711
- 2022039
- 9680845
- 3022296393
- 3008005217
- 3007113445
- 3003622434
- 3010864832
- 2511556
- 2023950
- 3014683120
- 3013508670
- 3006805063
- 3031841433
- 9612300
- 3008912871
- 3006697692
- 3012996495
- 1000118628
- 3004109528
- 1413475
- 3027241817
- 3032163716
- 3013410675
- 9681210
- 2126683
- 8010908
- 3012421607
- 1000272892
- 3032763783
- 3015272949
- 2027375
- 3010065389
- 1450653
- 3012494290
- 3032027578
- 1424442
- 1410097
- 3008524225
- 3007210751
- 3004158247
- 1420052
- 3042272797
- 1718476
- 1718912
- 2018957
- 9611458
- 1420089
- 3002807050
- 1721647
Source Documents#
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| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | 2018-01-17 |
| K160782 | BracePaste Adhesive | American Orthodontics | 2016-10-14 |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | 2016-10-06 |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | 2015-07-16 |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | 2015-05-07 |