| Primary Device ID | D8199007360 |
| NIH Device Record Key | 7ec2adeb-8da4-49ea-8494-67b768f0e187 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Printed Pre-Formed Left Cantilever 10mm (Single) |
| Version Model Number | 900736 |
| Company DUNS | 106645484 |
| Company Name | SPECIALTY APPLIANCES, LLC |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | D8199007360 [Primary] |
| ECN | Clamp, Wire, 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 | 2025-02-17 |
| Device Publish Date | 2025-02-07 |
| D8199007350 - Printed Pre-Formed Left Cantilever 8mm (Single) | 2025-02-17 |
| D8199007360 - Printed Pre-Formed Left Cantilever 10mm (Single) | 2025-02-17 |
| D8199007360 - Printed Pre-Formed Left Cantilever 10mm (Single) | 2025-02-17 |
| D8199007380 - Printed Pre-Formed Left Cantilever 12mm (Single) | 2025-02-17 |
| D8199007390 - Printed Pre-Formed Left Cantilever 14mm (Single) | 2025-02-17 |
| D8199007400 - Printed Pre-Formed Right Cantilever 8mm (Single) | 2025-02-17 |
| D8199007410 - Printed Pre-Formed Right Cantilever 10mm (Single) | 2025-02-17 |
| D8199007420 - Printed Pre-Formed Right Cantilever 12mm (Single) | 2025-02-17 |
| D8199007430 - Printed Pre-Formed Right Cantilever 14mm (Single) | 2025-02-17 |