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TT Transformer
TT TOOTH TRANSFORMER SRL · Model 01 · UDI-DI 08055728580008
10
510(k) clearances
18,194
Adverse events
27
Recalls
147
Facilities
Description
AC-powered Medical Device which allows automatic preparation of dentinal autologous material, starting from a tooth of a patient, in order to make it usable for bone regeneration, by the action of a motor that provides power to operate blades that reduce the tooth into granules.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-15 | Pro-Dex Inc | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch |
| 2018-09-25 | Pro-Dex Inc | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. |
| 2017-03-28 | Aesculap Implant Systems LLC | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m |
| 2017-03-28 | Aesculap Implant Systems LLC | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m |
| 2017-03-28 | Aesculap Implant Systems LLC | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.