The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Vera Pds & Vera Pdi.
| Device ID | K915249 |
| 510k Number | K915249 |
| Device Name: | VERA PDS & VERA PDI |
| Classification | Alloy, Metal, Base |
| Applicant | AALBA DENT, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer AALBA DENT, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90852187007197 | K915249 | 000 |
| 90852187007173 | K915249 | 000 |
| 90852187007142 | K915249 | 000 |
| 90852187007128 | K915249 | 000 |