510(k) K952927
- Device
- IMPACT AIR 45 4-HOLE
- Applicant
- PALISADES PHARMACEUTICS, INC.
- 510(k) number
- K952927
- Product code
- EFB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-06
- Date received
- 1995-06-26
- Regulation
- 872.4200
- Classification name
- Handpiece, Air-powered, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- CYNTHIA ROMANOFF
- Address
- 64 N. Summit St. Tenafly NJ US 07670 07670
FDA Registration Numbers
- 3013576763
- 3002696493
- 8030987
- 3003114027
- 3007031016
- 9614446
- 3006113289
- 3017619674
- 3002807636
- 2246821
- 1061053
- 3013287728
- 9614726
- 3006847937
- 3006540014
- 2086043
- 3012187973
- 2011171
- 3004096429
- 3017604
- 3007279848
- 3008770655
- 3003637274
- 3008912871
- 3005405362
- 3004884150
- 3002105090
- 3019381139
- 8043296
- 2024980
- 8010468
- 3038718579
- 8044015
- 3010364969
- 3010864832
- 2916440
- 3012336822
- 3003917473
- 3011300255
- 2031508
- 3003266594
- 3005581016
- 2520265
- 3030235916
- 3007007357
- 8043629
- 2320721
- 3015729
- 8044167
- 2032725
- 1032227
- 3003418325
- 1422375
- 9614977
- 1648564
- 1413475
- 3014471275
- 8032033
- 3030126955
- 3014953747
- 3002808149
- 3009391651
- 2183301
- 2133714
- 9611253
- 1718912
- 3007958831
- 3000219976
- 9614686
- 3021283891
- 3023861999
- 1054713
- 1941138
- 3022516928
- 1419489
- 2027754
- 9681479
- 8010493
- 3009074216
- 3009768364
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00851213006040 | Impact Air 45® | PALISADES DENTAL L.L.C | 2020-04-20 |
| 00851213006033 | Impact Air 45® | PALISADES DENTAL L.L.C | 2020-04-20 |
| 00851213006026 | Impact Air 45® | PALISADES DENTAL L.L.C | 2020-04-20 |
| 00851213006019 | Impact Air 45® | PALISADES DENTAL L.L.C | 2020-04-20 |
| 00851213006002 | Impact Air 45® | PALISADES DENTAL L.L.C | 2020-04-20 |
Other 510(k) Records For Product Code EFB
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|---|---|---|---|
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | 2026-01-12 |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. | 2026-01-12 |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | 2025-02-28 |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-11-13 |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co., Ltd. | 2024-11-12 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | 2024-09-20 |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | 2024-04-30 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | 2024-04-25 |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2023-09-22 |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | 2023-08-23 |
| K230888 | Titanium Turbine | Nakanishi, Inc. | 2023-06-02 |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023-02-22 |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | 2022-12-12 |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | 2022-11-17 |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-09-28 |
Legacy Summary
summary
FDA Review
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