OPTIBOND— 510(k) K940513

Substantially Equivalent

Kerr Corporation (Danbury)

FDA 510(k) clearance K940513 for OPTIBOND, Substantially Equivalent on 1994-04-15. Applicant: Kerr Corporation (Danbury). Device class: 2.

Clearance details

Applicant: Kerr Corporation (Danbury)
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1994-02-04
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, 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 Kerr Corporation (Danbury)

K051545 — L.E. DEMETRON II2005-07-18
K020091 — OPTILUX 5012002-03-21
K951663 — TYTIN R1995-06-06
K951511 — TYTIN ADMIX1995-05-02
K942480 — M4 CONTRA-ANGLE HANDPIECE1995-01-27

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