StarDental 266071
GUDID D7022660710
Aeras 500 Elite Handpiece, Lubricated, Fiber Optic
DENTALEZ, INC.
Dental power tool system handpiece, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic| Primary Device ID | D7022660710 |
| NIH Device Record Key | c8fab3c9-d905-4ce2-99fd-a6b1a98b7864 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarDental |
| Version Model Number | 266071 |
| Catalog Number | 266071 |
| Company DUNS | 059010363 |
| Company Name | DENTALEZ, 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx | |
| Phone | 1-866-383-4636 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7022660710 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192412
FDA Product Code
| EFB | Handpiece, Air-Powered, Dental |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
[D7022660710]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-17 |
| Device Publish Date | 2020-02-07 |
On-Brand Devices [StarDental ]
| D7022660720 | Aeras 500 Elite Handpiece, Lubricated, non-Fiber Optic |
| D7022660710 | Aeras 500 Elite Handpiece, Lubricated, Fiber Optic |
| D7022660650 | Aeras 500 Swivel, non-Fiber Optic |
| D7022660640 | Aeras 500 Swivel, Fiber Optic |
| D7022660410 | Aeras 500 Elite Handpiece, LubeFree non Fiber Optic |
| D7022660400 | Aeras 500 Elite Handpiece, LubeFree, Fiber Optic |
Trademark Results [StarDental]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STARDENTAL 73409489 1309837 Live/Registered |
Syntex (U.S.A.) Inc. 1983-01-14 |
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