OPTIGUARD— 510(k) K945539

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K945539 for OPTIGUARD, Substantially Equivalent on 1994-12-29. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1994-11-14
Decision date: 1994-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Sybron Dental Specialties, Inc.

K093341 — CENTURY MODEL 105C2010-04-05
K091091 — SONICFILL 20102009-10-14
K080089 — SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS2008-09-04
K073478 — SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS2008-09-03
K071615 — FIXAFLOSS2007-09-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.