| Primary Device ID | 00810042121324 |
| NIH Device Record Key | 748d8c8b-3e19-46a4-8481-7495abf636a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSE |
| Version Model Number | 5530-404 |
| Company DUNS | 077801124 |
| Company Name | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY 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 | false |
| 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 | 00810042121324 [Primary] |
| DZC | 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 | 2020-05-12 |
| Device Publish Date | 2020-05-04 |
| 00869843000284 | POSI-Lock™ Light Cure Flowable Composite Syringe |
| 00869843000277 | POSI-Lock™ Light Cure Flowable Composite Kit |
| 00869843000260 | Zinc Phosphate Cement Powder |
| 00869843000253 | Zinc Phosphate Cement Kit |
| 00869843000246 | Glass Ionomer Cement |
| 00810042122482 | Super Elastic Nickel Titanium Archwires Natural Form .017 x .025 Upper |
| 00810042122475 | Super Elastic Nickel Titanium Archwires Natural Form .016 x .022 Upper |
| 00810042122468 | Super Elastic Nickel Titanium Archwires Natural Form .016 x .016 Upper |
| 00810042123946 | ULTIMATE Ball Clasps .028 |
| 00810042121157 | Bonding Pads - Central Narrow |
| 00810042121140 | Bonding Pads - Lower Anterior |
| 00810042121133 | Bonding Pads - Cuspid Wide |
| 00810042121126 | Bonding Pads - Central Wide |
| 00810042120068 | Bonding Pads - Lateral |
| 00810042120051 | Bonding Pads - Bicuspid Narrow |
| 00810042121379 | Strengtheners - Stainless Steel, Bag of 50 |
| 00810042121164 | Labial Archwires - Maxillary 1-3\4" |
| 00810042121119 | 100 Split Stops and Spacers - .021 x .025 |
| 00810042121102 | 6" X 6" Stainless Steel Wire Mesh - Coarse |
| 00810042121096 | 6" X 6" Stainless Steel Wire Mesh - Fine |
| 00810042121089 | Lingual Bars - Extra Large |
| 00810042121072 | Lingual Bars - Large |
| 00810042121065 | Lingual Bars - Medium |
| 00810042121058 | Lingual Bars - Small |
| 00810042121041 | Arrowhead Clasps - .032 |
| 00810042121034 | Arrowhead Clasps - .028 |
| 00810042121027 | Round Buccal Tubing - .051 |
| 00810042121010 | Round Buccal Tubing - .045 |
| 00810042121003 | Round Buccal Tubing - .040 |
| 00810042122116 | Stainless Steel Closed Coil Spring - 3 x 12" - .010 x .030 |
| 00810042124455 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .017 x .025 Upper |
| 00810042124448 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 x .022 Upper |
| 00810042124431 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 x .016 Upper |
| 00810042124424 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .018 Lower |
| 00810042124417 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 Lower |
| 00810042124400 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .014 Lower |
| 00810042124394 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .013 Lower |
| 00810042124387 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .018 Upper |
| 00810042124370 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 Upper |
| 00810042124363 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .014 Upper |
| 00810042124356 | COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .013 Upper |
| 00810042124226 | Nickel Titanium Open Coil Spring .014 x .036 - 15" |
| 00810042124219 | Nickel Titanium Open Coil Spring .014 x .036 - 21" |
| 00810042124202 | Nickel Titanium Open Coil Spring .012 x .036 - 15" |
| 00810042124196 | Nickel Titanium Open Coil Spring .012 x .030 - 15" |
| 00810042124189 | Nickel Titanium Open Coil Spring .012 x .030 - 21" |
| 00810042124172 | Nickel Titanium Open Coil Spring .012 x .045 - 15" |
| 00810042124165 | Nickel Titanium Open Coil Spring .010 x .030 - 15" |
| 00810042124158 | Nickel Titanium Open Coil Spring .010 x .030 - 21" |
| 00810042124141 | Nickel Titanium Open Coil Spring .010 x .036 - 15" |