510(k) K851715
- Device
- 830/4 TO 848/7 VARIOUS TYPES CHISELS
- Applicant
- ARTIBERIA
- 510(k) number
- K851715
- Product code
- EML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-11
- Date received
- 1985-04-25
- Regulation
- 872.4565
- Classification name
- Chisel, Bone, Surgical
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GIL M SANCHEZ
- Address
- 4518 Los Ranchitos San Antonio TX US 78233 78233
FDA Registration Numbers#
- 9611278
- 5906
- 1057946
- 3010687973
- 3010041511
- 3027556548
- 9616250
- 3017521423
- 3025338240
- 3005061536
- 3030644259
- 3036795921
- 1835251
- 3014829979
- 3008797953
- 1032347
- 3012130008
- 1835998
- 9613083
- 1421879
- 1646747
- 2424531
- 3017352116
- 3014615697
- 9611367
- 9610905
- 2521453
- 9680026
- 1412854
- 3031564283
- 3000270450
- 3003905396
- 3003418325
- 8043554
- 3015895045
- 8030607
- 3004168759
- 3003334541
- 3011215096
- 3005273623
- 3013946322
- 3007648354
- 3011600579
- 3043355002
- 3013552516
- 8010697
- 8044098
- 9680002
- 3011164188
- 1422507
- 2249529
- 3008902714
- 9611062
- 3034676720
- 3000286616
- 3035708926
- 3015177652
- 3005067367
- 3005809810
- 3004992978
- 8039053
- 3003963832
- 1219518
- 3025603301
- 9611283
- 3012101664
- 2087382
- 3021666757
- 3008936260
- 3002808270
- 2529846
- 9680244
- 9611274
- 1032227
- 8010159
- 8040278
- 3006059835
- 3007064566
- 3015398570
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EML #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823320 | DENTAL INSTRUMENTS - BONE CHISELS | Miltex, Inc. | 1982-11-24 |
Legacy Summary#
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FDA Review#
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