Quolis AU-BDS5170
GUDID 04952195089406
QUOLIS PMU WITH ASSISTANT ARM
TAKARA-BELMONT CO., LTD.
Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system| Primary Device ID | 04952195089406 |
| NIH Device Record Key | 5c140364-742a-4dc2-a7b5-415f9e36afd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quolis |
| Version Model Number | Quolis |
| Catalog Number | AU-BDS5170 |
| Company DUNS | 690540349 |
| Company Name | TAKARA-BELMONT CO., LTD. |
| 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 | false |
| Manufacturing Date | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04952195089406 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072273
FDA Product Code
| NRD | Unit, Operative Dental, Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-10 |
| Device Publish Date | 2020-11-02 |
Devices Manufactured by TAKARA-BELMONT CO., LTD.
| 04952195406692 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light POST MOUNT TYPE |
| 04952195406708 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light POST MOUNT TYPE |
| 04952195406715 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light CEILING MOUNT TYPE |
| 04952195406722 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light TRACK MOUNT TYPE |
| 04952195406739 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light UNIT MOUNT TYPE |
| 04952195406746 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light UNIT MOUNT TYPE |
| 04952195406753 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light CABINET MOUNT TYPE |
| 04952195406760 - Bel-Halo Dental Light | 2023-06-26 Bel-Halo Dental Light WALL MOUNT TYPE |
Trademark Results [Quolis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUOLIS 76679552 3570311 Live/Registered |
TAKARA BELMONT USA, INC. 2007-07-16 |
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