The following data is part of a premarket notification filed by Dentsply International with the FDA for Xeno Nm Light Cured Dental Adhesive.
| Device ID | K041343 |
| 510k Number | K041343 |
| Device Name: | XENO NM LIGHT CURED DENTAL ADHESIVE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0026680121 | K041343 | 000 |
| D0026680050 | K041343 | 000 |
| D0026426051 | K041343 | 000 |