ALASTIGARD— 510(k) K890529

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K890529 for ALASTIGARD, Substantially Equivalent on 1989-03-09. Applicant: Unitek Corp.. Device class: 1.

Clearance details

Applicant: Unitek Corp.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1989-02-02
Decision date: 1989-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJF

K994357 — BITEM LOCK, MODELS SW006, SW0122000-03-14
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 Unitek Corp.

K944286 — METAL-LINED TRANSCEND CERAMIC BRACKET1994-11-29
K940165 — ALASTIK1994-03-07
K923999 — ALASTIK NS1993-06-24
K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS1992-11-25
K924295 — DEBRACKETING INSTRUMENT1992-11-23

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