510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123118Substantially Equivalent

Insignia Digicast

Ormco Corp., Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123118 is the FDA 510(k) clearance record for INSIGNIA DIGICAST, a class II device, cleared for Ormco Corp. on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list 12 510(k) clearances for Ormco Corp., from to . As of , FDA records show no recalls naming K123118.

Clearance record

Decision date
Received
(174 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Ormco Corp. 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DYW

Trailing 12 months
1 clearance under product code DYW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DYW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260