510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853758Substantially Equivalent

Py-Rite

Golden Dental Products, Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853758 is the FDA 510(k) clearance record for PY-RITE, a class I device, cleared for Golden Dental Products, Inc. on under FDA product code NJH (Lens, Spectacle (Prescription), For Reading Discomfort). FDA's definition for product code NJH reads: "Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error". FDA records list one 510(k) clearance for Golden Dental Products, Inc. As of , FDA records show no recalls naming K853758.

Clearance record

Decision date
Received
(85 days to decision)
Product code
NJH Lens, Spectacle (Prescription), For Reading Discomfort
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Applicant
Golden Dental Products, Inc. 16000 W. 76th. Ave., Golden CO
Third party review
No

Clearances, product code NJH

Trailing 12 months

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

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