Tenax Fiber Trans
GUDID D661TFT13C0
TENAX FIBER TRANS 1.3 REFILL
COLTENE/WHALEDENT INC
Root canal post, preformed| Primary Device ID | D661TFT13C0 |
| NIH Device Record Key | a2edec35-ae9e-40c2-9565-f29b8e5ecb0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tenax Fiber Trans |
| Version Model Number | TFT13C |
| Company DUNS | 622185718 |
| Company Name | COLTENE/WHALEDENT INC |
| Device Count | 5 |
| 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 |
Customer Support Contacts
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com | |
| Phone | 3309168800 |
| info@coltene.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D661TFT13C0 [Unit of Use] |
| HIBCC | D661TFT13C1 [Primary] |
FDA Product Code
| ELR | Post, Root Canal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
[D661TFT13C0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
On-Brand Devices [Tenax Fiber Trans]
| D661TFT15C0 | TENAX FIBER TRANS 1.5 REFILL |
| D661TFT13C0 | TENAX FIBER TRANS 1.3 REFILL |
| D661TFT11C0 | TENAX FIBER TRANS 1.1 REFILL |
| D661TFT150 | TENAX Fiber Trans Size 1.5 |
| D661TFT130 | TENAX Fiber Trans Size 1.3 |
| D661TFT11B0 | TENAX Fiber Trans Size 1.1 |
| D661TFT110 | TENAX Fiber Trans Size 1.1 |
| D661TFT10 | TENAX Fiber Trans One-Office-Visit Technique |
| D661600226610 | TENAX Fiber Trans Size 1.5 |
| D6616002266010 | TENAX Fiber Trans Size 1.3 |
| D661600226590 | TENAX Fiber Trans Size 1.1 |
| D661600199100 | TENAX Fiber Trans Training Kit |
| D661600185760 | Tenax Fiber Trans Size 1.5 |
| D6616001857510 | Tenax Fiber Trans Size 1.3 |
| D661600185740 | Tenax Fiber Trans Size 1.1 |
Trademark Results [Tenax Fiber Trans]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENAX FIBER TRANS 78839057 3600336 Live/Registered |
COLTENE/WHALEDENT, INC. 2006-03-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.