| Primary Device ID | 00614950027897 |
| NIH Device Record Key | 1702b9eb-3197-4dbd-b881-f4b0b3e2a4f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFINTY EXTERNAL HEX SYSTEM |
| Version Model Number | 2053535 |
| Catalog Number | 2053535 |
| Company DUNS | 042763706 |
| Company Name | ACE SURGICAL SUPPLY CO., INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
|---|---|
| GS1 | 00614950027897 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
| 00614950028597 | INTERNAL HEX SCANNING ABUTMENT. 4.5 MM PLAT ANT CH 13MM TITAN |
| 00614950028566 | Clinical Scan Body Ti |
| 00614950028559 | Clinical Scan Body Ti |
| 00614950028542 | Clinical Scan Body Ti |
| 00614950028535 | Clinical Scan Body Ti |
| 00614950028269 | infinity External Hex Surgical Kit |
| 00614950028252 | infinity Dental Implant System TRI-CAM Surgical Kit |
| 00614950028139 | Clinical Scan Body Posterior |
| 00614950028122 | Clinical Scan Body Posterior |
| 00614950028115 | Clinical Scan Body Posterior |
| 00614950028108 | Clinical Scan Body Posterior |
| 00614950028092 | Clinical Scan Body Anterior |
| 00614950028085 | Clinical Scan Body Anterior |
| 00614950027903 | INTERNAL HEX OPEN TRAY IMPRESSION COPING 4.5 STRAIGHT |
| 00614950027897 | INTERNAL HEX OPEN TRAY IMPRESSION COPING 3.5 STRAIGHT |
| 00614950027880 | INTERNAL HEX CLOSED TRAY IMPRESSION COPING 4.5 STRAIGHT |
| 00614950027873 | INTERNAL HEX CLOSED TRAY IMPRESSION COPING 3.5 STRAIGHT |
| 00614950027798 | OCTOGON MULTI-UNIT ABUTMENT PROSTHETIC SCREW FOR SCS |
| 00614950027781 | MUA GOLD/PLASTIC COPING NO SCREW |
| 00614950027774 | MULTI-UNIT DRIVER |
| 00614950027767 | MUA SCANNING ABUTMENT W/PROSTHETIC SCREW |
| 00614950027750 | OCTOGON MULTI UNIT ABUTMENT GUIDE PIN WITH SCS APEX |
| 00614950027743 | OCTOGON MULTI UNIT TITANIUM TEMPORARY FOR SCS |
| 00614950027736 | OCTOGON MULTI UNIT ABUTMENT SCREW AMGLED NARROW/REGULAR |
| 00614950027729 | OCTAGON TITANIM ABUTMENT BL/NC (NP) |
| 00614950027651 | MUA INTERNAL HEX PROSTHETIC ANGLED ABUTMENT SCREW |
| 00614950027644 | INTERNAL HEX MULTI-UNIT GUIDE PIN WITH .050 HEX |
| 00614950027637 | INTERNAL HEX MULTI UNIT ABUTMENT 4.5 PLATFORM X2MM H |
| 00614950027620 | INTERNAL HEX 30 DEG MULTI UNIT ABUTMENT 4.5 X3MM H |
| 00614950027613 | INTERNAL HEX LAB SCREW PACKGAGE OF 5 |
| 00614950027576 | INTERNAL HEX MULTI-UNIT ABUTMENT 4.5 PLATFORM X3MM H. 17 DEG ANG |
| 00614950027569 | INTERNAL HEX MULTI-UNIT ABUTMENT 3.5 PLATFORM X1MM H. STRAIGHT |
| 00614950027491 | INTERNAL HEX SCANNING ABUTMUNT 3.5MM PLATFORM 6.5MM H |
| 00614950027460 | INTERNAL HEX TEMPORARY ABUTMENT NON-ENGAGING 4.5MM |
| 00614950027453 | INTERNAL HEX TEMPORARY ABUTMENT ENGAGING 4.5MM |
| 00614950027446 | INTERNAL HEX TEMPORARY ABUTMENT ENGAGING 3.5MM |
| 00614950027439 | MUA INTERNAL HEX PROSTHETIC SCREW |
| 00614950027422 | MUA IMPRESSION COPING CLOSED TRAY |
| 00614950027415 | OCTAGON TITANIUM SCREW FOR TITANIUM BASE BL/RC (RP) |
| 00614950027408 | OCTAGON TITANIUM SCREW FOR TITANIUM BASE BL/NC (NP) |
| 00614950027392 | OCTAGON TITANIM ABUTMENT BL/RC (RP) |
| 00614950027378 | INTRNAL HEX UCLA GOLD ABUTMENT 4.5MM PLATFORM ENGAGING |
| 00614950027361 | INTRNAL HEX UCLA GOLD ABUTMENT 3.5MM PLATFORM ENGAGING |
| 00614950027354 | INTERNAL HEX 30 DEG MULTI UNIT ABUTMENT 3.5 X3MM H |
| 00614950027347 | INTERNAL HEX 17 DEG MULTI UNIT ABUTMENT 3.5 X2MM H |
| 00614950027316 | INTERNAL HEX MULTI-UNIT ABUTMENT 3.5 PLATFORM X3MM H. 17 DEG ANG |
| 00614950027170 | MUA IMPRESSION COPING OPEN TRAY |
| 00614950027101 | MUA ANALOG |