510(k) K822464
- Device
- Obturation Gutta
- Applicant
- U.S. SHIZAI CORP.
- 510(k) number
- K822464
- Product code
- EKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-03
- Date received
- 1982-08-16
- Regulation
- 872.4565
- Classification name
- File, Margin Finishing, Operative
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3005440795
- 3005831677
- 1416605
- 2024312
- 3006531065
- 2183301
- 3009968482
- 8040278
- 3003361112
- 3004193466
- 2241860
- 1419982
- 1422507
- 3009171220
- 9680026
- 9616119
- 3009340886
- 3008808049
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830764 | FR ROOT CANAL SEALER | Shizai Corp. | 1983-07-26 |