510(k) K965026
- Device
- PFINGST PRESSURE PASTE
- Applicant
- PFINGST & CO., INC.
- 510(k) number
- K965026
- Product code
- EFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-10
- Date received
- 1996-12-17
- Regulation
- 872.6140
- Classification name
- Paper, Articulation
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID PFINGST
- Address
- 105 Snyder Rd. South Plainfield, NJ US 07080 07080
FDA Registration Numbers#
- 2431400
- 3021023132
- 8010224
- 3011713204
- 2431224
- 3004425647
- 8030938
- 3006316962
- 3012312751
- 3008370577
- 3003418325
- 3006621353
- 1836161
- 1215305
- 3003600526
- 3010131268
- 3008822460
- 1044031
- 3009171220
- 3014334038
- 1319130
- 8010629
- 3007255375
- 3003120666
- 3011526299
- 8010414
- 3038632739
- 3011632
- 3005344591
- 3018799047
- 3038718579
- 2429849
- 3013641573
- 3017910185
- 3023339277
- 2411797
- 2086043
- 9613083
- 2241860
- 1043617
- 2018957
- 3016447764
- 1836229
- 8010827
- 3010583458
- 3012101632
- 3023443842
- 2183301
- 2437780
- 3015045320
- 2515379
- 3012996495
- 3043648115
- 1221639
- 3012421607
- 8044177
- 3024088964
- 3013557562
- 3005558160
- 2024312
- 2523320
- 3025307990
- 3009307523
- 3006542438
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912632 | OCCLUDE | Pascal Co., Inc. | 1992-01-17 |
| K911259 | HYDENT | Pascal Co., Inc. | 1991-06-06 |
| K864572 | FIXTECTOR | Prodent Intl., Inc. | 1987-02-12 |
| K870032 | REVISED T-SCAN SYSTEM | Sentek, Inc. | 1987-02-02 |
| K832647 | ARTICULATING PAPER | Ardent Intl., Inc. | 1984-02-21 |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. | 1984-02-10 |
| K810498 | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. | 1981-03-17 |
| K771011 | ARTICULATING PAPER | Parker Laboratories, Inc. | 1977-06-20 |
| K770492 | CRACK DETECTOR, DEN-MAT | Dey-Mat, Inc. | 1977-03-21 |
Legacy Summary#
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FDA Review#
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