510(k) K823320
- Device
- DENTAL INSTRUMENTS - BONE CHISELS
- Applicant
- MILTEX, INC.
- 510(k) number
- K823320
- Product code
- EML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-24
- Date received
- 1982-11-08
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008808049
- 8043507
- 1032347
- 9616250
- 1828464
- 3003882387
- 8044098
- 3043355002
- 3005809810
- 3011137372
- 3025338240
- 1223843
- 3004168759
- 3002675176
- 3033509898
- 3007064566
- 3015393204
- 3009171220
- 3017352116
- 3008338766
- 3011499367
- 3002808270
- 2521453
- 3008902714
- 3031564283
- 3001620590
- 3001644167
- 3015895045
- 9611062
- 1417592
- 3010288346
- 3000286616
- 3006059835
- 8010697
- 3005092287
- 3013946322
- 3015512299
- 1419489
- 3003969055
- 3030644259
- 9611281
- 3007773213
- 2085199
- 9611274
- 1833053
- 3014615697
- 9681622
- 1644408
- 9611283
- 3004193466
- 3015177652
- 3010041511
- 8040278
- 8039053
- 3003988575
- 3029082594
- 9680026
- 1835251
- 3009340886
- 3013552516
- 8041151
- 1836161
- 8043554
- 9610905
- 9611367
- 2916714
- 9613083
- 3012101664
- 3005273623
- 3019404837
- 3036795921
- 9616246
- 1646747
- 3010536692
- 1421879
- 3017521423
- 1722824
- 3003334541
- 1416605
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EML #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851715 | 830/4 TO 848/7 VARIOUS TYPES CHISELS | Artiberia | 1985-06-11 |
Legacy Summary#
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FDA Review#
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