510(k) K771974
- Device
- SOLVENEX I-0
- Applicant
- DEN-MAT CORP.
- 510(k) number
- K771974
- Product code
- KZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-12
- Date received
- 1977-10-17
- Regulation
- 872.3750
- Classification name
- Solution, Cement Dissolving
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2018957
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KZP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920843 | TOOTH CONDITIONER | Confi-Dental Products Co. | 1993-04-08 |
Legacy Summary#
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FDA Review#
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