Dentauraum, Inc.
Newtown, PA, US
Dentauraum, Inc. appears in FDA device records in Newtown, PA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Dentauraum, Inc. between 1991 and 1995. The busiest year on record is 1994, with 17. The most recent is 1995, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 17 |
| 1995 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952870 | REMANIUM: CS & G-SOFT | EJH | Substantially Equivalent | |
| K952867 | REMANIUM:GM 700, GM 380, GM 800, GFH | EJH | Substantially Equivalent | |
| K952866 | REMATITAN TITANIUM | EJH | Substantially Equivalent | |
| K952865 | REMANIUM: 200,CS, 380, AND CD | EJH | Substantially Equivalent | |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | EBL | Substantially Equivalent | |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | KMY | Substantially Equivalent | |
| K942666 | ORTHALGENAT IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K936151 | EXTRAORAL HEADGEAR | DZB | Substantially Equivalent | |
| K942668 | O-TRAY IMPRESSION TRAYS | EHY | Substantially Equivalent | |
| K942665 | ORTHOCENT: LIQUID AND POWDER | EMA | Substantially Equivalent | |
| K935856 | DENTAURUM SPACE MAINTAINER | DYT | Substantially Equivalent | |
| K935155 | MERSHON BAND PUSHER | ECS | Substantially Equivalent | |
| K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | ECI | Substantially Equivalent | |
| K935140 | DENTAURUM STEEL LIGATURE WIRES | DZC | Substantially Equivalent | |
| K935139 | FASCINATION CERAMIC BRACKET | EJF | Substantially Equivalent | |
| K935156 | DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS | ECR | Substantially Equivalent | |
| K935154 | DENTAURUM EXPANSION SCREWS | DYJ | Substantially Equivalent | |
| K935153 | DENTAURUM BRACKET POSITIONING GAUGE | ECQ | Substantially Equivalent | |
| K935152 | DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD | DYO | Substantially Equivalent | |
| K935143 | DENTAURUM STAINLESS STEEL TUBING | DZD | Substantially Equivalent | |
| K935142 | DENTAURUM WIRES | DZC | Substantially Equivalent | |
| K935141 | DENTAURUM PLIERS | JEX | Substantially Equivalent | |
| K935122 | DENTAURUM METAL BRACKETS | EJF | Substantially Equivalent | |
| K902018 | DENTAURUM CERAMIC DEBONDING UNIT | EKS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- ECQAligner, Bracket, Orthodontic
- EJHAlloy, Metal, Base
- ECIBand, Elastic, Orthodontic
- DYOBand, Material, Orthodontic
- EJFBracket, Metal, Orthodontic
- EMACement, Dental
- EKSFile, Pulp Canal, Endodontic
- DZBHeadgear, Extraoral, Orthodontic
- DYTMaintainer, Space Preformed, Orthodontic
- ELWMaterial, Impression
- EBLPin, Retentive And Splinting, And Accessory Instruments
- JEXPlier, Orthodontic
- KMYPositioner, Tooth, Preformed
- ECSPusher, Band, Orthodontic
- DYJRetainer, Screw Expansion, Orthodontic
- ECRSetter, Band, Orthodontic
- EHYTray, Impression, Preformed
- DZDTube, Orthodontic
- DZCWire, Orthodontic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain