510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951776Substantially Equivalent

Band Seater

Ormco Corp., Glendora CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951776 is the FDA 510(k) clearance record for BAND SEATER, a class I device, cleared for Ormco Corp. on under FDA product code ECR (Setter, Band, Orthodontic). FDA records list 27 510(k) clearances for Ormco Corp., from to . As of , FDA records show no recalls naming K951776.

Clearance record

Decision date
Received
(40 days to decision)
Product code
ECR Setter, Band, Orthodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Ormco Corp. 1332 S. Lone Hill Ave., Glendora CA
510(k) summary
Summary
Third party review
No

Clearances, product code ECR

Trailing 12 months

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

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