Elements Connect
GUDID 08809455601921
Elements Connect Cordless Motor Kit - US
META SYSTEMS CO., LTD.
Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric| Primary Device ID | 08809455601921 |
| NIH Device Record Key | 7b4c2425-2e2d-47d8-8315-e99ff9037d2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elements Connect |
| Version Model Number | 815-1800 |
| Company DUNS | 687503532 |
| Company Name | META SYSTEMS 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 | true |
| Manufacturing Date | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809455601921 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210475
FDA Product Code
| EKX | Handpiece, Direct Drive, Ac-Powered |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
[08809455601921]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-25 |
| Device Publish Date | 2022-11-17 |
On-Brand Devices [Elements Connect]
| 08809455601952 | Elements Connect Charging Base |
| 08809455601945 | Elements Connect Contra Angle |
| 08809455601938 | Elements Connect Motor Handpiece |
| 08809455601921 | Elements Connect Cordless Motor Kit - US |
| 08809455601402 | Elements Connect Cordless Motor Kit - EU |
Trademark Results [Elements Connect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELEMENTS CONNECT 86109600 4559673 Live/Registered |
Zywave, Inc. 2013-11-04 |
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