510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935638Substantially Equivalent

Nitinol, Niti

G & H Wire Company, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935638 is the FDA 510(k) clearance record for NITINOL, NITI, a class I device, cleared for Highland Metals on under FDA product code DZC (Wire, Orthodontic). FDA records list 9 510(k) clearances for G & H Wire Company, from to . As of , FDA records show no recalls naming K935638.

Clearance record

Decision date
Received
(176 days to decision)
Product code
DZC Wire, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Highland Metals 1801 Almaden Rd., San Jose 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