| Primary Device ID | J006500105220 |
| NIH Device Record Key | feabe09b-7eff-4919-ac5f-040a985a3182 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alpen Diamond Instruments |
| Version Model Number | R848C018FG |
| Catalog Number | R848C018FG |
| Company DUNS | 480017482 |
| Company Name | Coltène/Whaledent AG |
| Device Count | 5 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J006500105220 [Unit of Use] |
| HIBCC | J006R848C018FG0 [Primary] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
[J006500105220]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-18 |
| Device Publish Date | 2022-08-10 |