Ceramill
83 catalogue numbers from A-Temp B2 98x14, listed by Amann Girrbach AG, Austria, under Crown And Bridge, Long-Term Temporary, Resin. 1 manufacturer in China is registered for this product code.
1manufacturer
83catalogue numbers in this listing
Who Else Makes It
Registered in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
Record
| Listed by | Amann Girrbach AG, Austria |
|---|---|
| FDA product code | POW |
| Device type | Crown And Bridge, Long-Term Temporary, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3770 |
| Establishment | Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191843 |
| Record published | 2019-10-28 |
| Record revised | 2025-10-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-03-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-Temp B2 98×14 | In distribution | |
| A-Temp C2 B40 UN | In distribution | |
| A-Temp B2 B55 UN | In distribution | |
| A-Temp A3 98×20 | In distribution | |
| Ceramill A-Temp ML 0/A1 98×16 | In distribution | |
| A-Temp C2 98×16 | In distribution | |
| A-Temp A3 98×16 | In distribution | |
| A-Temp A1 98×14 | In distribution | |
| A-Temp B2 98×16 | In distribution | |
| A-Temp A3,5 B55 UN | In distribution | |
| A-Temp A3 98×14 | In distribution | |
| Ceramill A-Temp ML A2/A3 98×14 | In distribution | |
| A-Temp A3,5 B40 UN | In distribution | |
| Ceramill A-Temp ML C1/C2 98×16 | In distribution | |
| A-Temp A1 98×16 | In distribution | |
| Ceramill A-Temp ML C1/C2 98×20 | In distribution | |
| Ceramill A-Temp ML B2/B3 98×16 | In distribution | |
| A-Temp C2 B55 UN | In distribution | |
| A-Temp C2 98×20 | In distribution | |
| A-Temp A1 B55 UN | In distribution | |
| Ceramill A-Temp ML A2/A3 98×16 | In distribution | |
| Ceramill A-Temp ML A2/A3 98×20 | In distribution | |
| A-Temp A3,5 98×16 | In distribution | |
| A-Temp A2 B55 UN | In distribution | |
| A-Temp A3 B40 UN | In distribution | |
| A-Temp A2 98×16 | In distribution | |
| A-Temp A1 98×20 | In distribution | |
| Ceramill A-Temp ML C1/C2 98×14 | In distribution | |
| Ceramill A-Temp ML 0/A1 98×14 | In distribution | |
| A-Temp A3,5 98×20 | In distribution | |
| A-Temp A3 B55 UN | In distribution | |
| A-Temp A1 B40 UN | In distribution | |
| A-Temp C2 98×14 | In distribution | |
| A-Temp A2 98×14 | In distribution | |
| A-Temp B2 B40 UN | In distribution | |
| A-Temp A3,5 98×14 | In distribution | |
| Ceramill A-Temp ML 0/A1 98×20 | In distribution | |
| Ceramill A-Temp ML B2/B3 98×14 | In distribution | |
| A-Temp A2 B40 UN | In distribution | |
| A-Temp B2 98×20 | In distribution | |
| A-Temp A2 98×20 | In distribution | |
| Ceramill A-Temp ML B2/B3 98×20 | In distribution | |
| A-Temp A3 71×14 | Withdrawn | |
| A-Temp C2 B55 | Withdrawn | |
| A-Temp A1 B40 | Withdrawn | |
| Ceramill A-Temp ML 0/A1 71×16 | Withdrawn | |
| A-Temp A3,5 B40 | Withdrawn | |
| A-Temp A2 71×20 | Withdrawn | |
| A-Temp A3,5 71×20 | Withdrawn | |
| Ceramill A-Temp ML C1/C2 71×20 | Withdrawn | |
| A-Temp B2 71×14 | Withdrawn | |
| A-Temp A3 71×16 | Withdrawn | |
| A-Temp A3 71×20 | Withdrawn | |
| A-Temp C2 B40 | Withdrawn | |
| A-Temp A2 71×14 | Withdrawn | |
| A-Temp A1 B55 | Withdrawn | |
| A-Temp B2 71×16 | Withdrawn | |
| A-Temp A3 B55 | Withdrawn | |
| A-Temp A2 B40 | Withdrawn | |
| Ceramill A-Temp ML B2/B3 71×16 | Withdrawn | |
| Ceramill A-Temp ML A2/A3 71×14 | Withdrawn | |
| A-Temp A3,5 71×16 | Withdrawn | |
| Ceramill A-Temp ML C1/C2 71×16 | Withdrawn | |
| Ceramill A-Temp ML C1/C2 71×14 | Withdrawn | |
| Ceramill A-Temp ML A2/A3 71×16 | Withdrawn | |
| A-Temp C2 71×20 | Withdrawn | |
| A-Temp B2 B40 | Withdrawn | |
| Ceramill A-Temp ML A2/A3 71×20 | Withdrawn | |
| A-Temp A1 71×20 | Withdrawn | |
| A-Temp A2 B55 | Withdrawn | |
| A-Temp C2 71×16 | Withdrawn | |
| Ceramill A-Temp ML B2/B3 71×20 | Withdrawn | |
| Ceramill A-Temp ML 0/A1 71×14 | Withdrawn | |
| A-Temp A3 B40 | Withdrawn | |
| A-Temp A3,5 71×14 | Withdrawn | |
| A-Temp A3,5 B55 | Withdrawn | |
| A-Temp A1 71×14 | Withdrawn | |
| Ceramill A-Temp ML B2/B3 71×14 | Withdrawn | |
| A-Temp B2 71×20 | Withdrawn | |
| A-Temp C2 71×14 | Withdrawn | |
| A-Temp A1 71×16 | Withdrawn | |
| Ceramill A-Temp ML 0/A1 71×20 | Withdrawn | |
| A-Temp B2 B55 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Temp Premium Flexible | Zirkonzahn SRL | 198 |
| Temp Basic | Zirkonzahn SRL | 189 |
| Temp Premium | Zirkonzahn SRL | 165 |
| Therapon Transpa | Zirkonzahn SRL | 34 |
| LuxaCrown | DMG Chemisch Pharmazeutische Fabrik Gmbh | 8 |
| Multistratum Flexible | Zirkonzahn SRL | 8 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.