510(k) K202674
- Device
- Medidenta High Speed Handpieces
- Applicant
- Pac-Dent, Inc.
- 510(k) number
- K202674
- Product code
- EFB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-12
- Date received
- 2020-09-15
- Regulation
- 872.4200
- Classification name
- Handpiece, Air-Powered, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jiahe Li
- Address
- 670 Endeavor Cir. Brea CA US 92821 92821
FDA Registration Numbers
- 2032725
- 3003114027
- 3008912871
- 3003934980
- 1032227
- 9614686
- 3002807636
- 3009074216
- 1054713
- 3008770655
- 8043629
- 3004884150
- 8043296
- 3012187973
- 3006847937
- 8044015
- 9681479
- 1718912
- 9614726
- 1941138
- 3000219976
- 2087470
- 3014471275
- 2027754
- 3022516928
- 3013576763
- 9614977
- 2031508
- 3010864832
- 1419489
- 2024980
- 3015729
- 3012477813
- 3003917473
- 2246821
- 3012421607
- 3006540014
- 3009391651
- 2523320
- 2320721
- 3006113289
- 3003637274
- 3005405362
- 3017619674
- 3002105090
- 3030235916
- 3002696493
- 3002808149
- 3003266594
- 8032033
- 3013287728
- 9611253
- 3007007357
- 3010364969
- 9614446
- 8044167
- 1422375
- 3014683120
- 2183301
- 3038718579
- 2133714
- 3007958831
- 8010493
- 3004096429
- 3005581016
- 3030126955
- 3009768364
- 1413475
- 2520265
- 3004082152
- 8030987
- 3012336822
- 8010468
- 3021283891
- 3007279848
- 3023861999
- 3029780
- 2916440
- 2086043
- 3019381139
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFB
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|---|---|---|---|
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| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023-02-22 |
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