| Primary Device ID | 00810126508249 |
| NIH Device Record Key | c0c597e8-13bd-4fca-8543-b15b2d175530 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Basik by 3D Dental |
| Version Model Number | BPGC316T |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810126508249 [Primary] |
| GS1 | 10810126508246 [Package] Package: Box/12 [12 Units] In Commercial Distribution |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-19 |
| Device Publish Date | 2026-03-11 |
| 00817169022497 | PDO USP 4/0 -1/2 circ. Tappered needle 17mm Suture |
| 00817169022480 | PDO USP 3/0 -1/2 circ. Tapered needle 26mm Suture |
| 00817169022473 | PDO USP 2/0 1/2 circ. Tapered needle 26MM Suture |
| 00817169022466 | PDO USP 0 1/2 CIRC REV CUTTING NEEDLE 36MM Suture |
| 00810126508263 | PGC SUTURE USP 5/0 1/2 Circle Taper point NEEDLE 17MM LENGTH 75CM Inner Single |
| 00810126508256 | PGC SUTURE USP 4/0 1/2 Circle Taper point NEEDLE 17MM LENGTH 75CM Inner Single |
| 00810126508249 | PGC SUTURE USP 3/0 1/2 Circle Taper point NEEDLE 36MM LENGTH 75CM Inner Single |
| 00810126508232 | PGC SUTURE USP 2/0 1/2 Circle Taper point NEEDLE 36MM LENGTH 75CM Inner single |