510(k) K871493
- Device
- Denti-tray(tm)
- Applicant
- ADVANCED MEDICAL, INC.
- 510(k) number
- K871493
- Product code
- EKW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-24
- Date received
- 1987-04-16
- Regulation
- 872.4565
- Classification name
- Broach, Endodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTOR H PEREIRA
- Address
- 17744 Sampson Ln.-Unit 7 Huntington Beach CA US 92647 92647
FDA Registration Numbers#
- 8043792
- 3012101632
- 3004569445
- 3021284315
- 3007064566
- 3011210208
- 9611053
- 3017498782
- 8031011
- 3010864832
- 3011824442
- 1836161
- 3013538161
- 8031010
- 3014326245
- 3008370577
- 3019567808
- 3011554142
- 3010145273
- 3012501675
- 9616128
- 3008249935
- 3003882387
- 1032227
- 3007791573
- 3015136927
- 3001644167
- 9615399
- 3009171220
- 8030607
- 8030343
- 9680913
- 3003418325
- 3010160527
- 3002692886
- 3042866301
- 8030962
- 2320721
- 8030938
- 3011713204
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870765 | CANNULATED INSTRUMENT CLEANERS | Treace Medical, Inc. | 1987-05-27 |
| K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | Walter Lorenz Surgical, Inc. | 1986-08-01 |
| K831749 | ENDODONTIC BROACH(76EKN) BARBED BROACH | Union Branch | 1983-07-12 |
| K823489 | ENDODONTIC BROACH-BARBED BROACH | Union Broach, Div. Moyco Industries, Inc. | 1982-12-15 |
| K800292 | ENDEX BROACH, ENDODONTIC | Ipco Corp. | 1980-02-19 |
| K760985 | HAND INSTRUMENTS | Adp Intl., Inc. | 1976-11-15 |