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#
- 3002769835
- 3008808049
- 9614075
- 1419247
- 9680026
- 3027615
- 3011600579
- 3014829979
- 2520265
- 1419982
- 8041151
- 8040881
- 3012101664
- 3027556548
- 8040278
- 1032227
- 3013946322
- 1422507
- 3003882387
- 3013552516
- 3005809810
- 3010155661
- 3043355002
- 9681622
- 3019404837
- 8043554
- 1419489
- 2916714
- 3003334541
- 3038718579
- 3008902714
- 3045853999
- 9611367
- 3008797953
- 3004193466
- 3006059835
- 3015895045
- 3011625373
- 1421879
- 1836161
- 3021666757
- 3003905396
- 3011499367
- 3031564283
- 9610809
- 3010288346
- 3008770252
- 9680244
- 2080222
- 3043047788
- 3003877407
- 3005831677
- 3005587147
- 3009703496
- 3005973280
- 9614986
- 2183301
- 3011215096
- 9612086
- 5906
- 9611503
- 3008309654
- 3012421607
- 3029082594
- 3003969055
- 3001408183
- 2521453
- 3005621335
- 3003407244
- 2431166
- 8010159
- 1720747
- 3007751820
- 3010353847
- 3048101437
- 9610612
- 3005092287
- 9680735
- 3002808270
- 2246990
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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