510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970930Substantially Equivalent

Bilateral Infant Cleft Palate Orthodontic Appliance

Cleft Palate Appliances, Inc., London, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970930 is the FDA 510(k) clearance record for BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE, a class I device, cleared for Cleft Palate Appliances, Inc. on under FDA product code DYJ (Retainer, Screw Expansion, Orthodontic). FDA records list one 510(k) clearance for Cleft Palate Appliances, Inc. As of , FDA records show no recalls naming K970930.

Clearance record

Decision date
Received
(41 days to decision)
Product code
DYJ Retainer, Screw Expansion, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Cleft Palate Appliances, Inc. 218 Commisioners Rd., W., London, CA
510(k) summary
Summary
Third party review
No

Clearances, product code DYJ

Trailing 12 months

FDA records hold no clearances under product code DYJ in the trailing twelve months.

FDA records show no clearances under product code DYJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260