| Primary Device ID | D909800022S1 |
| NIH Device Record Key | 3d1070b9-d401-4f8d-ad8b-785f15509307 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPECTRUM |
| Version Model Number | 800-022S |
| Company DUNS | 020956330 |
| Company Name | Ortho Arch 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 | false |
| 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 | D909800022S1 [Primary] |
| JEX | Plier, 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 | 2025-09-23 |
| Device Publish Date | 2025-09-15 |
| D9098001281 | SPECTRUM LOOP FORMING & CLOSING PLIER |
| D9098001271 | SPECTRUM THREE PRONG CLASP PLIER |
| D9098001251 | SPECTRUM UTILITY ARCH 3MM STEP PLIER |
| D9098001241 | SPECTRUM ANGLED UTILITY ARCH PLIER |
| D9098001231 | SPECTRUM UTILITY ARCH PLIER |
| D9098000881 | SPECTRUM LOOP TIE BACK PLIER |
| D9098000871 | SPECTRUM GTS CRIMPING PLIER |
| D9098000741 | SPECTRUM ADHESIVE REMOVER |
| D909800063A1 | SPECTRUM ANTERIOR BRACKET REMOVER |
| D9098000631 | SPECTRUM DIRECT BOND BRACKET REMOVER - ANGLED |
| D9098000611 | SPECTRUM OPTICAL PLIER (OCCULIST) |
| D9098000441 | SPECTRUM TWEED LOOP FORMING PLIERS |
| D9098001321 | SPECTRUM THREE PRONG FACEMASK/ FACEBOW PLIER |
| D9098001311 | SPECTRUM WIDE REPLACEMENT KEY |
| D9098001302 | SPECTRUM TORQUING PLIER SET W/ WIDE KEY |
| D9098001290 | SPECTRUM LINGUAL ARCH FORMING PLIER |
| D90980008518 | SPECTRUM POSTERIOR HOOK CRIMPING PLIER***DISCONTINUED/ WHILE SUPPLIES LAST. NONREFUNDABLE OR RET |
| D90980008417 | SPECTRUM STOP CRIMPING PLIER***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RETURNABLE** |
| D909800063C1 | SPECTRUM DEBONDING PLIERS ANGLED ***discontinued*** |
| D9098000331 | SPECTRUM HEAVY DUTY CUTTER (up to .060) |
| D909800022S1 | SPECTRUM MINI DISTAL NITI WIRE CRIMPER***DISCONTINUED/ WHILE SUPPLIES LAST. NON-REFUNDABLE OR RE |
| D9098000041 | SPECTRUM WEINGART UTILITY PLIERS |