| Primary Device ID | 00810059290433 |
| NIH Device Record Key | 7e792629-59b1-492f-bedd-64599cd78441 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Denovo general purpose dental molar band - Mandibular size L25 |
| Version Model Number | 160-250 |
| Company DUNS | 183498179 |
| Company Name | Denovo Dental, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810059290433 [Primary] |
| ECM | Band, Preformed, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-10 |
| Device Publish Date | 2023-06-30 |
| 00810059290006 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U23 |
| 00810059290013 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U23.5 |
| 00810059290020 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U24 |
| 00810059290037 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U24.5 |
| 00810059290044 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U25 |
| 00810059290051 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U25.5 |
| 00810059290068 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U26 |
| 00810059290075 - Denovo general purpose dental molar band | 2023-07-10 Denovo general purpose dental molar band - Maxillary size U26.5 |