510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231793Substantially Equivalent

RODIN 3D Resin SPLINT, Hard/Flex

Belport Company, Inc., Gingi-Pak, Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K231793 is the FDA 510(k) clearance record for RODIN 3D Resin SPLINT, Hard/Flex, cleared for Belport Company, Inc., Gingi-Pak on under FDA product code MQC (Mouthguard, Prescription). FDA records list 11 510(k) clearances for Belport Company, Inc., Gingi-Pak, from to . As of , FDA records show no recalls naming K231793.

Clearance record

Decision date
Received
(280 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Belport Company, Inc., Gingi-Pak 4825 Calle Alto, Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code MQC

Trailing 12 months
2 clearances under product code MQC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260