Medical Device Manufacturer · US , Newtown , PA

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

24 submissions · 24 cleared · Since 1991

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentauraum, Inc. Dental ✕

24 devices

1-24 of 24

Cleared Jul 27, 1995

REMATITAN TITANIUM

Cleared Jul 27, 1995

REMANIUM:GM 700, GM 380, GM 800, GFH

Cleared Jul 27, 1995

REMANIUM: CS & G-SOFT

Cleared Jul 26, 1995

REMANIUM: 200,CS, 380, AND CD

Cleared Jul 19, 1995

DENTAURUM JACKET CROWN & ROOT POSTS

Cleared Feb 13, 1995

DENT-O-CRYL ORTHODONTIC ACRYLIC

Cleared Aug 10, 1994

ORTHALGENAT IMPRESSION MATERIAL

Cleared Aug 01, 1994

EXTRAORAL HEADGEAR

Cleared Jul 22, 1994

ORTHOCENT: LIQUID AND POWDER

Cleared Jul 22, 1994

O-TRAY IMPRESSION TRAYS

Cleared Apr 28, 1994

DENTAURUM SPACE MAINTAINER

Cleared Feb 04, 1994

FASCINATION CERAMIC BRACKET

Cleared Feb 04, 1994

DENTAURUM STEEL LIGATURE WIRES

Cleared Feb 04, 1994

DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS

Cleared Feb 04, 1994

MERSHON BAND PUSHER

Cleared Feb 03, 1994

DENTAURUM EXPANSION SCREWS

Cleared Feb 03, 1994

DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS

Cleared Jan 31, 1994

DENTAURUM METAL BRACKETS

Cleared Jan 31, 1994

DENTAURUM PLIERS

Cleared Jan 31, 1994

DENTAURUM WIRES

Cleared Jan 31, 1994

DENTAURUM STAINLESS STEEL TUBING

Cleared Jan 31, 1994

DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD

Cleared Jan 31, 1994

DENTAURUM BRACKET POSITIONING GAUGE

Cleared Apr 03, 1991

DENTAURUM CERAMIC DEBONDING UNIT