ORTHOJOIN, ORTHODONTIC ADHESIVE— 510(k) K861118

Substantially Equivalent

Ortho Source

FDA 510(k) clearance K861118 for ORTHOJOIN, ORTHODONTIC ADHESIVE, Substantially Equivalent on 1986-05-02. Applicant: Ortho Source. Device class: 2.

Clearance details

Applicant: Ortho Source
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1986-03-25
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Hollywood, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortho Source

K913853 — FISSURE SEALER1992-08-27
K913854 — ORTHO LIGHT CURE1992-01-14
K913519 — SUMO GLASS IONOMER CEMENT1991-11-19
K884949 — VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER1989-02-23
K884575 — MAXIBOND1989-01-03

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