ION-IMPLANTED NEO SENTALLOY— 510(k) K932025

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K932025 for ION-IMPLANTED NEO SENTALLOY, Substantially Equivalent on 1993-09-13. 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: 1993-04-26
Decision date: 1993-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJF

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K932825 — MICROARCH GOLD BRACKET1994-05-09
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
K942826 — ORTHODONITC METAL REINFORCED PLASTIC BRACKET1994-12-14
K933542 — MESIAL LOOP BAR1994-08-05
K932319 — ORTHODONTIC ELASTOMER1993-09-20
K920905 — BIOFORCE WIRE1992-11-04

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