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#
- 3006059835
- 3014829979
- 1057946
- 3017352116
- 1032347
- 3007648354
- 3015177652
- 2246990
- 3008812560
- 1828464
- 3015895045
- 1722824
- 3027556548
- 2085199
- 9616246
- 3003988575
- 9611274
- 1421101
- 2521453
- 3005273623
- 3019404837
- 3002808270
- 1416605
- 8010159
- 3031564283
- 3008770252
- 3002769835
- 3007773213
- 1833053
- 3003877407
- 3009340886
- 3015393204
- 1836161
- 3003905396
- 3007064566
- 3004892425
- 3003244954
- 9610612
- 3009241418
- 3010288346
- 1417592
- 3008902714
- 3004193466
- 8030607
- 3015882686
- 8043752
- 3009049852
- 3003418325
- 3036795921
- 3010687973
- 1056350
- 1419489
- 3014615697
- 1422507
- 3005809810
- 8010733
- 8040278
- 9680026
- 2529846
- 1219518
- 3004168759
- 8043554
- 3003407244
- 3045811395
- 9610905
- 1835998
- 3015512299
- 8010665
- 3009968482
- 5906
- 2916714
- 9611281
- 3010353847
- 2431166
- 3017521423
- 9613926
- 3005067367
- 3034676720
- 9611283
- 2080222
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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