The following data is part of a premarket notification filed by Recherches Techniques Dentaires (r.t.d.) with the FDA for Quartz Splint System (ud, Woven, Rope, Mesh) Quartz Spint Resin Qs Flow.
| Device ID | K122348 |
| 510k Number | K122348 |
| Device Name: | QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) 3 RUE LOUIS NEEL St. Egreve, FR 38120 |
| Contact | Manh-quynh Chu |
| Correspondent | Manh-quynh Chu RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) 3 RUE LOUIS NEEL St. Egreve, FR 38120 |
| Product Code | EBI |
| Subsequent Product Code | EBF |
| Subsequent Product Code | EBG |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2012-10-15 |
| Summary: | summary |