# K122348: Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow

- Pathway: 510(k) (Traditional)
- Applicant: Recherches Techniques Dentaires (R.T.D.)
- Decided: Oct 15, 2012 after 73 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003333 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011788: Everstick, Stick Tech, Ltd. (2001) Summary page 1.
- K972985: Splint IT, Jeneric/Pentron, Inc. (1997) Summary page 1.
- K031341: Stick Flow, Stick Tech, Ltd. (2003) Summary page 3.
- (no number) Ribbond: named in the summary without a submission number

## Indications for use
The splinting system is designed for use in oral splintings otto support laboratory-processes composite bridge/denture work * QUARTZ SPLINT"" UD (Unidirectional): Composite laboratory bridge strengthening/ reinforcement * QUARTZ SPLINTTM WOVEN: Direct Splinting/Bridge and Implant positioning reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy. * QUARTZ SPLINrM ROPE: Laboratory splint fabrication for bridge reinforcemnent or denture repair. Periodontal splinting of mobile teeth iitClinical use. * QUARTZ SPLINTTM MESH: Denture reinforcement and denture repair: * QUARTZ SPLINT"' RESIN: for additional wetting during the application of the finished splints * QS.FLOWTm: a nano filIed, light cured flowable composite designed to be used with the QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.

Source page: https://510kreport.com/device/K122348
Methodology: https://510kreport.com/methodology