CERAMIC ORTHODONIT APPLIANCE— 510(k) K852179

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K852179 for CERAMIC ORTHODONIT APPLIANCE, Substantially Equivalent on 1985-08-20. Applicant: Gac Intl., Inc.. Device class: 1.

Clearance details

Applicant: Gac Intl., Inc.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1985-05-20
Decision date: 1985-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commack, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJF

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K933501 — ALASTIK1994-04-28
K923372 — MEMORY WIRE1994-04-22
K933080 — ORTHOTECH DURA-GOLD BARCKETS1994-03-23

More clearances from Gac Intl., Inc.

K981036 — SMARTBOND1999-04-05
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K933542 — MESIAL LOOP BAR1994-08-05
K932319 — ORTHODONTIC ELASTOMER1993-09-20
K932025 — ION-IMPLANTED NEO SENTALLOY1993-09-13

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