510(k) K022032
- Device
- ACETAL
- Applicant
- INOVATIV, LLC
- 510(k) number
- K022032
- Product code
- EHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-29
- Date received
- 2002-06-21
- Regulation
- 872.3285
- Classification name
- Clasp, Preformed
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BOWERS
- Address
- 1155 Twin Hills Dr. Jefferson OR US 97352 97352
FDA Registration Numbers#
- 3005014825
- 3005344553
- 3004992978
- 3010032042
- 2523320
- 2081322
- 1526352
- 3014425175
- 8010342
- 3007320533
- 8040278
- 8044058
- 8010874
- 3009171220
- 3009711592
- 8010019
- 1316408
- 3017903664
- 3008524225
- 3001561923
- 1718476
- 3006942327
- 3006207978
- 9611458
Source Documents#
Other 510(k) Records For Product Code EHP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983558 | ACETAL DENTAL/PREFORMED CLASP | Dentamax, Inc. | 1999-01-07 |
| K974622 | DENTAL D | Micro Dental Laboratories | 1998-02-10 |
| K954971 | ACETAL DENTAL/PREFORMED CLASP | B & H Technical Services , Ltd. | 1995-12-11 |
| K955946 | ACETAL DENTAL/PREFORMED CLASP | Pressing DI Monticelli Rag. Stefano | 1995-12-11 |
| K854765 | INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH | C&C Systems, Inc. | 1986-06-13 |
| K800574 | VACUDENT LUMIX 65 | Vacudent Sales Corp. | 1980-05-20 |
| K800575 | VACUDENT LUMIX 70 | Vacudent Sales Corp. | 1980-05-20 |
Legacy Summary#
summary
FDA Review#
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