ClearanceBrief
Company ยท US

Coltene, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2004. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
ELWMaterial, Impression6
EBFMaterial, Tooth Shade, Resin2
EJJAlloy, Amalgam2
DYHAdhesive, Bracket And Tooth Conditioner, Resin1
EBGCrown And Bridge, Temporary, Resin1
EIDSyringe, Restorative And Impression Material1
EKSFile, Pulp Canal, Endodontic1
EMACement, Dental1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 13, 2004K041098COOL TEMP NATURAL
Coltene AG
EBG
Sep 18, 2002K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
Coltene AG
DYH
Aug 28, 1990K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL
Coltene, Inc.
EMA
Sep 23, 1988K882800COLTENE PRESIDENT JET REGULAR BODY
Coltene, Inc.
ELW
Oct 27, 1987K873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM
Coltene, Inc.
EKS
Feb 27, 1987K870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM
Coltene, Inc.
EBF
Jan 29, 1987K870047COLTENE RAPID
Coltene, Inc.
ELW
Oct 30, 1986K863998COLTENE JET-MIXER
Coltene, Inc.
EID
Feb 8, 1985K850036COLTENE PRECISE
Coltene, Inc.
ELW
Mar 16, 1984K840297COLTENE ORALLOY MAGICAPS
Coltene, Inc.
EJJ
Jul 15, 1981K811767COLTENE PRESIDENT IMPRESSION MATERIALS
Coltene, Inc.
ELW
Jul 15, 1981K811667COLTENE PRESSURE SPOT INDICATOR
Coltene, Inc.
ELW
Jul 15, 1981K811666COLTENE COLTEX/COLTOFLAX
Coltene, Inc.
ELW
Jun 16, 1981K811363COLTENE DRS DENTAL RESTORATIVE SYSTEM
Coltene, Inc.
EBF
Apr 23, 1981K810907COLTENE ORALLY
Coltene, Inc.
EJJ

Latest recalls

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