OPTIBOND 2— 510(k) K012322

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K012322 for OPTIBOND 2, Substantially Equivalent on 2001-08-30. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2001-07-23
Decision date: 2001-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

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.