Not currently registered with FDA under this name
Dentauraum, Inc.
Newtown, PA, United States. Named as applicant on 24 dental 510(k) clearances between 1991 and 1995. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 241991–1995
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Dentauraum, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Jul 1995 | K952870 | REMANIUM: CS & G-SOFT | EJH Base Metal Alloy |
| 27 Jul 1995 | K952867 | REMANIUM:GM 700, GM 380, GM 800, GFH | EJH Base Metal Alloy |
| 27 Jul 1995 | K952866 | REMATITAN TITANIUM | EJH Base Metal Alloy |
| 26 Jul 1995 | K952865 | REMANIUM: 200,CS, 380, AND CD | EJH Base Metal Alloy |
| 19 Jul 1995 | K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | EBL Retentive and Splinting Pin and Accessory Instruments |
| 13 Feb 1995 | K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | KMY Preformed Tooth Positioner |
| 10 Aug 1994 | K942666 | ORTHALGENAT IMPRESSION MATERIAL | ELW Impression Material |
| 1 Aug 1994 | K936151 | EXTRAORAL HEADGEAR | DZB Orthodontic Extraoral Headgear |
| 22 Jul 1994 | K942668 | O-TRAY IMPRESSION TRAYS | EHY Preformed Impression Tray |
| 22 Jul 1994 | K942665 | ORTHOCENT: LIQUID AND POWDER | EMA Dental Cement |
| 28 Apr 1994 | K935856 | DENTAURUM SPACE MAINTAINER | DYT Orthodontic Space Preformed Maintainer |
| 4 Feb 1994 | K935155 | MERSHON BAND PUSHER | ECS Orthodontic Band Pusher |
| 4 Feb 1994 | K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | ECI Orthodontic Elastic Band |
| 4 Feb 1994 | K935140 | DENTAURUM STEEL LIGATURE WIRES | DZC Orthodontic Wire |
| 4 Feb 1994 | K935139 | FASCINATION CERAMIC BRACKET | EJF Orthodontic Metal Bracket |
| 3 Feb 1994 | K935156 | DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS | ECR Orthodontic Band Setter |
| 3 Feb 1994 | K935154 | DENTAURUM EXPANSION SCREWS | DYJ Orthodontic Screw Expansion Retainer |
| 31 Jan 1994 | K935153 | DENTAURUM BRACKET POSITIONING GAUGE | ECQ Orthodontic Bracket Aligner |
| 31 Jan 1994 | K935152 | DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD | DYO Orthodontic Material Band |
| 31 Jan 1994 | K935143 | DENTAURUM STAINLESS STEEL TUBING | DZD Orthodontic Tube |
| 31 Jan 1994 | K935142 | DENTAURUM WIRES | DZC Orthodontic Wire |
| 31 Jan 1994 | K935141 | DENTAURUM PLIERS | JEX Orthodontic Plier |
| 31 Jan 1994 | K935122 | DENTAURUM METAL BRACKETS | EJF Orthodontic Metal Bracket |
| 3 Apr 1991 | K902018 | DENTAURUM CERAMIC DEBONDING UNIT | EKS Endodontic Pulp Canal File |
Some of these clearances are listed with FDA today by another company: Dentaurum GmbH & Co. KG (6).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.