NEW ACE
GUDID D080SSNEWXXL5XLXD30
YAMAHACHI DENTAL MFG.,CO.
Resin artificial teeth| Primary Device ID | D080SSNEWXXL5XLXD30 |
| NIH Device Record Key | d50de275-36e1-44de-ac0e-6adc6773d15d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEW ACE |
| Version Model Number | 6*1SET,L5,L,D3 |
| 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 | 04582275821116 [Secondary] |
| HIBCC | D080SSNEWXXL5XLXD30 [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 | 2023-06-12 |
| 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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