The following data is part of a premarket notification filed by Denterprise International, Inc. with the FDA for Dental X-ray Z70 (w); Dental X-ray Z70 (m); Dental X-ray Z70 (c).
| Device ID | K122582 |
| 510k Number | K122582 |
| Device Name: | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DENTERPRISE INTERNATIONAL, INC. 110 EAST GRANADA BLVD Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin DENTERPRISE INTERNATIONAL, INC. 110 EAST GRANADA BLVD Ormond Beach, FL 32176 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2012-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868923000275 | K122582 | 000 |
| 00868923000268 | K122582 | 000 |
| 00868923000251 | K122582 | 000 |
| 00868923000244 | K122582 | 000 |
| 00868923000237 | K122582 | 000 |
| 00868923000220 | K122582 | 000 |
| 00868923000213 | K122582 | 000 |
| 00868923000206 | K122582 | 000 |