Coltolux
GUDID D661C79701001150
COLTOLUX LED LIGHT CURING SYSTEM, 100/115V
COLTENE/WHALEDENT INC
Dental/surgical polymerization lamp| Primary Device ID | D661C79701001150 |
| NIH Device Record Key | bb93ca9a-ec9b-4f5e-98da-6ab31e1e36c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coltolux |
| Version Model Number | C7970100115 |
| Company DUNS | 622185718 |
| Company Name | COLTENE/WHALEDENT INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D661C79701001150 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040551
FDA Product Code
| EBZ | Activator, Ultraviolet, For Polymerization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-11-15 |
| Device Publish Date | 2016-06-07 |
Devices Manufactured by COLTENE/WHALEDENT INC
| 00840016202025 - BioSonic | 2025-02-28 US100r Power Cord Replacement |
| 00840016202032 - BioSonic | 2025-02-28 US100r Footswitch Replacement |
| 00840016202049 - BioSonic | 2025-02-28 US100r Handpiece Replacement |
| D661H083711 - Hyflex | 2025-02-04 Hyflex X-File SS #08 x 21mm File |
| D661H083721 - Hyflex | 2025-02-04 Hyflex X-File SS #10 x 21mm File |
| D661H083741 - Hyflex | 2025-02-04 Hyflex X-File NT #15 x 21mm File |
| D661H083761 - Hyflex | 2025-02-04 Hyflex X-File NT #20 x 21mm File |
| D661H083781 - Hyflex | 2025-02-04 Hyflex X-File NT #25 x 21mm File |
Trademark Results [Coltolux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLTOLUX 74444459 1841768 Live/Registered |
COLTENE/WHALEDENT, INC. 1993-10-07 |
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