510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965216Substantially Equivalent

Argi-Satin or Opti0-Star

Argen Precious Metals, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965216 is the FDA 510(k) clearance record for ARGI-SATIN OR OPTI0-STAR, a class II device, cleared for Argen Precious Metals, Inc. on under FDA product code ELL (Teeth, Porcelain). FDA records list 217 510(k) clearances for Argen Precious Metals, Inc., from to . As of , FDA records show no recalls naming K965216.

Clearance record

Decision date
Received
(59 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Argen Precious Metals, Inc. 5855 Oberlin Dr., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code ELL

Trailing 12 months

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

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