NEW ACE
GUDID D080SSNEWXXT3XUXB40
YAMAHACHI DENTAL MFG.,CO.
Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth| Primary Device ID | D080SSNEWXXT3XUXB40 |
| NIH Device Record Key | 40bb62ec-89d1-4add-a302-41ec22a28b50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEW ACE |
| Version Model Number | 6*1SET,T3,U,B4 |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04582275824896 [Secondary] |
| HIBCC | D080SSNEWXXT3XUXB40 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060507
FDA Product Code
| ELM | Denture, Plastic, Teeth |
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 | 2023-06-02 |
| Device Publish Date | 2018-02-02 |
On-Brand Devices [NEW ACE]
Trademark Results [NEW ACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEW ACE 72025575 0657839 Dead/Expired |
SUNSHINE PECAN COMPANY 1957-03-05 |
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