UNITEK DISPOSABLE IMPRESSION SYRINGE— 510(k) K851386

Name: FDA 510(k) clearance K851386
Creator: U.S. Food and Drug Administration
Published: 1985-04-29

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K851386 for UNITEK DISPOSABLE IMPRESSION SYRINGE, Substantially Equivalent on 1985-04-29. Applicant: Unitek Corp.. Device class: 1.

Clearance details

Applicant: Unitek Corp.
Product code: Code EID
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1985-04-09
Decision date: 1985-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EID

view all

K941431 — BONE GRAFT DELIVERY SYRINGES1994-07-12
K913974 — ACCESS IMPRESSION BARREL1992-02-25
K873153 — CAULK'S VPS CARTRIDGE SYSTEM1987-09-16
K871937 — IMPRESSION SYRINGE1987-06-05
K863998 — COLTENE JET-MIXER1986-10-30

More clearances from Unitek Corp.

view all

K944286 — METAL-LINED TRANSCEND CERAMIC BRACKET1994-11-29
K933501 — ALASTIK1994-04-28
K940165 — ALASTIK1994-03-07
K923999 — ALASTIK NS1993-06-24
K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS1992-11-25

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