510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061042Substantially Equivalent

Linglock

Sybron Dental Specialties, Inc., Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061042 is the FDA 510(k) clearance record for LINGLOCK, a class II device, cleared for Sybron Dental Specialties on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list 176 510(k) clearances for Sybron Dental Specialties, from to . As of , FDA records show no recalls naming K061042.

Clearance record

Decision date
Received
(280 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Sybron Dental Specialties 100 Bayview Cir., Newport Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DYW

Trailing 12 months

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

FDA records show no clearances under product code DYW in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260