COLTENE JET-MIXER— 510(k) K863998

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K863998 for COLTENE JET-MIXER, Substantially Equivalent on 1986-10-30. Applicant: Coltene, Inc.. Device class: 1.

Clearance details

Applicant: Coltene, Inc.
Product code: Code EID
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1986-10-14
Decision date: 1986-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EID

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
K853282 — CENTRIX RIBBON TUBES1985-08-23

More clearances from Coltene, Inc.

K902392 — COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL1990-08-28
K882800 — COLTENE PRESIDENT JET REGULAR BODY1988-09-23
K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM1987-10-27
K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM1987-02-27
K870047 — COLTENE RAPID1987-01-29

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