| Primary Device ID | 00190746156892 |
| NIH Device Record Key | 71ac827c-e081-400c-8077-2d6a2e4b8cc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lip Bumper |
| Version Model Number | 852-032950 |
| Catalog Number | 852-032950 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS CORPORATION |
| 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 |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746156892 [Primary] |
| DYJ | RETAINER, SCREW EXPANSION, 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 | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
| 00190746125096 | TUBE MINI MAND LEFT 1ST MOLAR 022/045 CAST CONV TQ-10 R=0 3.5MM W/HK HG GING R5 |
| 00190746125089 | TUBE MINI MAND RIGHT 1ST MOLAR 022/045 CAST CONV TQ-10 R=0 3.5MM W/HK HG GING R5 |
| 00190746125072 | TUBE MINI MAND LEFT 1ST MOLAR 018/045 CAST CONV TQ-10 R=0 3.5MM W/HK HG GING R5 |
| 00190746125065 | TUBE MINI MAND RIGHT 1ST MOLAR 018/045 CAST CONV TQ-10 R=0 3.5MM W/HK HG GING R5 |
| 00190746125058 | TUBE MINI MAND LEFT 1ST MOLAR 022/045 CAST CONV TQ=-25 R=6 3.5MM W/HOOK HG GING |
| 00190746125041 | TUBE MINI MAND RIGHT 1ST MOLAR 022/045 CAST CONV TQ=-25 R=6 3.5MM W/HOOK HG GING |
| 00190746125034 | TUBE MINI MAND LEFT 1ST MOLAR 018/045 CAST CONV TQ=-25 R=6 3.5MM W/HOOK HG GING |
| 00190746125027 | TUBE MINI MAND RIGHT 1ST MOLAR 018/045 CAST CONV TQ=-25 R=5 3.5MM W/HOOK HG GING |
| 00190746124839 | TUBE MAND LEFT 1ST MOLAR 022/018/045 CAST CONV TQ=-25 R=6 4.2MM W/ CAST HOOK |
| 00190746124822 | TUBE MAND RIGHT 1ST MOLAR 022/018/045 CAST CONV TQ=-25 R=6 4.2MM W/ CAST HK GING |
| 00190746124815 | TUBE MAND LEFT 1ST MOLAR 018/018/045 CAST CONV TQ=-25 R=6 4.2MM W/GING CAST |
| 00190746124808 | TUBE MAND RIGHT 1ST MOLAR 018/018/045 CAST CONV TQ=-25 R=6 4.2MM W/GING CAST |
| 00190746124792 | TUBE MAND LEFT 1ST MOLAR 022/018/045 CAST CONV TQ=-25 R=6 4.2MM W/ LB HOOK GING |
| 00190746124785 | TUBE MAND RIGHT 1ST MOLAR 022/018/045 CAST CONV TQ=-25 R=6 4.2MM W/ LB HOOK GING |
| 00190746124778 | TUBE MAND LEFT 1ST MOLAR 018/018/045 CAST CONV TQ=-25 R=6 4.2MM W/LB HOOK GING |
| 00190746124761 | TUBE MAND RIGHT 1ST MOLAR 018/018/045 CAST CONV TQ=-25 R=6 4.2MM W/LB HOOK GING |
| 00190746156922 | FIXED FUNCT LIP BUMPER 045 96MM BALL CLASP HK DIST TO LOOP |
| 00190746156915 | FIXED FUNCT LIP BUMPER 045 93MM BALL CLASP HK DIST TO LOOP |
| 00190746156908 | FIXED FUNCT LIP BUMPER 045 90MM BALL CLASP HK DIST TO LOOP |
| 00190746156892 | FIXED FUNCT LIP BUMPER 045 85MM BALL CLASP HK DIST TO LOOP |
| 00190746156885 | FIXED FUNCT LIP BUMPER W/O HK |
| 00190746073472 | LIP BUMPER 045 DIA W/CUSPID HOOKS KIT OF 14 |
| 00190746073465 | LIP BUMPER 045 DIA KIT OF 14 |
| 00190746073458 | LIP BUMPER 045 100MM SIZE 5 W/CUSPID HOOKS |
| 00190746073441 | LIP BUMPER 045 100MM SIZE 5 |
| 00190746073434 | LIP BUMPER 045 96MM SIZE 4 W/CUSPID HOOKS |
| 00190746073427 | LIP BUMPER 045 96MM SIZE 4 |
| 00190746073410 | LIP BUMPER 045 93MM SIZE 3 W/CUSPID HOOKS |
| 00190746073403 | LIP BUMPER 045 93MM SIZE 3 |
| 00190746073397 | LIP BUMPER 045 90MM SIZE 2 W/CUSPID HOOKS |
| 00190746073380 | LIP BUMPER 045 90MM SIZE 2 |
| 00190746073373 | LIP BUMPER 045 85MM SIZE 1 W/CUSPID HOOKS |
| 00190746073366 | LIP BUMPER 045 85MM SIZE 1 |
| 00190746073359 | LIP BUMPER 045 82MM SIZE 0 W/CUSPID HOOKS |
| 00190746073342 | LIP BUMPER 045 82MM SIZE 0 |
| 00190746073335 | LIP BUMPER 045 78MM SIZE 00 W/CUSPID HOOKS |
| 00190746073328 | LIP BUMPER 045 78MM SIZE 00 |
| 00190746174230 | KORN LIP BUMPER KIT 2 EA SIZE |
| 00190746174223 | KORN LIP BUMPER LOWER SMALL |
| 00190746174216 | KORN LIP BUMPER LOWER MEDIUM |
| 00190746174209 | KORN LIP BUMPER LOWER LARGE |
| 00190746174193 | KORN LIP BUMPER UPPER SMALL |
| 00190746151194 | KORN LIP BUMPER UPPER LARGE |