510(k) K031793
- Device
- DENTATUS OSCIOMAT
- Applicant
- Dentatus USA , Ltd.
- 510(k) number
- K031793
- Product code
- DZH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-13
- Date received
- 2003-06-10
- Regulation
- 872.4120
- Classification name
- Saw, Bone, Ac-Powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- RICHARD C LANZILLOTTO
- Address
- 30 Northport Rd. Sound Beach NY US 11789 11789
FDA Registration Numbers#
- 2020943
- 2832
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935443 | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS | Osada Electric Co., Ltd. | 1994-09-20 |
| K760958 | SURGICAL OSCILLATING SAW | American Safety Equipment Corp. | 1976-11-16 |
| K760957 | SURGICAL RECIPROCATING SAW | American Safety Equipment Corp. | 1976-11-15 |