Medical Device Manufacturer · US , Mchenry , IL

Coltene, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1981

Total

Cleared

Denied

Coltene, Inc. has 13 FDA 510(k) cleared dental devices. Based in Mchenry, US.

Historical record: 13 cleared submissions from 1981 to 1990.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

Coltene, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Coltene, Inc.

13 devices

1-12 of 13

Cleared Aug 28, 1990

COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL

K902392 · EMA

Dental · 90d

Cleared Sep 23, 1988

COLTENE PRESIDENT JET REGULAR BODY

K882800 · ELW

Dental · 78d

Cleared Oct 27, 1987

COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM

K873671 · EKS

Dental · 46d

Cleared Feb 27, 1987

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM

COLTENE ORALLOY MAGICAPS

K840297 · EJJ

Dental · 52d

Cleared Jul 15, 1981

COLTENE COLTEX/COLTOFLAX

K811666 · ELW

Dental · 30d

Cleared Jul 15, 1981

COLTENE PRESSURE SPOT INDICATOR

K811667 · ELW

Dental · 30d

Cleared Jul 15, 1981

COLTENE PRESIDENT IMPRESSION MATERIALS

K811767 · ELW

Dental · 23d

Cleared Jun 16, 1981

COLTENE DRS DENTAL RESTORATIVE SYSTEM

K811363 · EBF

Dental · 33d

Coltene, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Coltene, Inc.

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