510(k) K834055
- Device
- VANADIUM EXCAVATORS SIZES 0-6
- Applicant
- HENRY SCHEIN, INC.
- 510(k) number
- K834055
- Product code
- EKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-21
- Date received
- 1983-11-23
- Regulation
- 872.4565
- Classification name
- Excavator, Dental, Operative
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009968482
- 3003969055
- 3006059835
- 2431166
- 3005092287
- 3015177652
- 1419489
- 1416605
- 3005621335
- 3011164188
- 9611367
- 3010353847
- 9680735
- 1836161
- 3014257280
- 3011499367
- 3004168759
- 2246990
- 3014829979
- 9681622
- 9610809
- 3031564283
- 3001146947
- 9611899
- 3007751820
- 3008808049
- 3008902714
- 9610612
- 3005587147
- 3006410968
- 3005528784
- 9614986
- 9614069
- 3043239665
- 9612086
- 3010288346
- 3043047788
- 3003882387
- 8040278
- 3009171220
- 9610905
- 2183301
- 3003963832
- 9680026
- 2916714
- 3005809810
- 2521453
- 3014201171
- 3009703496
- 1032227
- 3021666757
- 8010159
- 1419982
- 3004992978
- 3036795921
- 3008309654
- 8043554
- 3001297506
- 9614075
- 3030644259
- 1720747
- 3027615
- 3019404837
- 3012101664
- 3005067367
- 3002769835
- 3029082594
- 3043355002
- 1057946
- 3001408183
- 3002808270
- 3005440795
- 8010732
- 1422507
- 3048101437
- 2531684
- 3013946322
- 9680244
- 8040881
- 3009513193
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851722 | 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS | Artiberia | 1985-07-02 |
Legacy Summary#
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FDA Review#
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