510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943334Substantially Equivalent

Hawley Retainer Orthodontic Applicance Kit

Jay H. Geller, Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943334 is the FDA 510(k) clearance record for HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT, a class I device, cleared for Jay H. Geller on under FDA product code DZC (Wire, Orthodontic). FDA records list 4 510(k) clearances for Jay H. Geller, from to . As of , FDA records show no recalls naming K943334.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DZC Wire, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Jay H. Geller East Tower, Suite 600, Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code DZC

Trailing 12 months

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

FDA records show no clearances under product code DZC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZC, 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