| Primary Device ID | E219J211250101 |
| NIH Device Record Key | 97d72ac9-32e7-4d58-858c-6a5546f42d7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bite registration cap |
| Version Model Number | J2112.5010 |
| Catalog Number | J2112.5010 |
| Company DUNS | 322018193 |
| Company Name | ALTATEC GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com | |
| Phone | 7609181857 |
| info@camlog.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E219J211250101 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-26 |
| Device Publish Date | 2023-12-18 |
| E219J211260101 | Bite registration cap, Ø 6.0 mm, PBT (6 units), sterile |
| E219J211250101 | Bite registration cap, Ø 5.0 mm, PBT (6 units), sterile |
| E219J211243101 | Bite registration cap, Ø 4.3 mm, PBT (6 units), sterile |
| E219J211238101 | Bite registration cap, Ø 3.8 mm, PBT (6 units), sterile |
| E219J211233101 | Bite registration cap, Ø 3.3 mm, PBT (6 units), sterile |