FIBER FORCE

Resin, Denture, Relining, Repairing, Rebasing

SYNCA MARKETING, INC.

The following data is part of a premarket notification filed by Synca Marketing, Inc. with the FDA for Fiber Force.

Pre-market Notification Details

• Device ID: K102207
• 510k Number: K102207
• Device Name: FIBER FORCE
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: SYNCA MARKETING, INC. 12946 KIMBERLEY LN Houston, TX 77079
• Contact: Dave Kim
• Correspondent: Dave Kim; SYNCA MARKETING, INC. 12946 KIMBERLEY LN Houston, TX 77079
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-05
• Decision Date: 2010-11-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
66714700001255	K102207	000
00667147000067	K102207	000
00667147000029	K102207	000
00667147000012	K102207	000
00667147000005	K102207	000
00667147100224	K102207	000
00667147100200	K102207	000
00667147100194	K102207	000
00667147100187	K102207	000
00667147100125	K102207	000
00667147100118	K102207	000
00667147100101	K102207	000
00667147100095	K102207	000
66714700001002	K102207	000
66714700001019	K102207	000
66714700001231	K102207	000
66714700001217	K102207	000
66714700001200	K102207	000
66714700001194	K102207	000
66714700001125	K102207	000
66714700001118	K102207	000
66714700001101	K102207	000
66714700001095	K102207	000
66714700001088	K102207	000
66714700001064	K102207	000
66714700001033	K102207	000
66714700001026	K102207	000
00667147100088	K102207	000