TRAXODENT
Cord, Retraction
PREMIER DENTAL PRODUCTS CO.
The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Traxodent.
Pre-market Notification Details
| Device ID | K083695 |
| 510k Number | K083695 |
| Device Name: | TRAXODENT |
| Classification | Cord, Retraction |
| Applicant | PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Contact | Vincent D'alessandro |
| Correspondent | Vincent D'alessandro PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-04-28 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00348783001020 | K083695 | 000 |
| 00348783001013 | K083695 | 000 |
| 00348783001006 | K083695 | 000 |
Trademark Results [TRAXODENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRAXODENT 77518925 3764272 Live/Registered |
Premier Dental Products Company 2008-07-10 |
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