| Primary Device ID | D764B10730511 |
| NIH Device Record Key | eeabefca-9e65-4399-9592-c133918e8bfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCHICK ELITE |
| Version Model Number | B1073051 |
| Company DUNS | 078613913 |
| Company Name | SIRONA DENTAL, INC. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | D764B10730511 [Primary] |
| HIBCC | D764B10730710 [Unit of Use] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2016-09-09 |
| D764B24010431 | SCHICK ELITE SIZE 1 WITH 3' CABLE ATTACHED |
| D764B10742541 | SCHICK AIMRIGHT - PERIAPICAL AUTOCLAVABLE HOLDERS - S2 (4) YELLOW |
| D764B10741531 | SCHICK AIMRIGHT - ANTERIOR AUTOCLAVABLE HOLDER S1 (2) WHITE |
| D764B10741301 | SCHICK AIMRIGHT AUTOCLAVABLE STARTER KIT - SIZE 1 |
| D764B10743301 | UNIVERSAL RING ADHESIVE HOLDER SYSTEM STARTER KIT |
| D764B10742531 | SCHICK AIMRIGHT - ANTERIOR AUTOCLAVABLE HOLDER S2 (2) WHITE |
| D764B10742521 | SCHICK AIMRIGHT - VERTICAL BITEWING AUTOCLAVABLE HOLDER S2 (2) BLUE |
| D764B10742511 | SCHICK AIMRIGHT - HORIZONTAL BITEWING AUTOCLAVABLE HOLDER S2 (2) BLUE |
| D764B10742301 | SCHICK AIMRIGHT AUTOCLAVABLE STARTER KIT - SIZE 2 |
| D764B10741541 | SCHICK AIMRIGHT - PERIAPICAL AUTOCLAVABLE HOLDERS - S1 (4) YELLOW |
| D764B10741521 | SCHICK AIMRIGHT - VERTICAL BITEWING AUTOCLAVABLE HOLDER S1 (2) BLUE |
| D764B10741511 | SCHICK AIMRIGHT - HORIZONTAL BITEWING AUTOCLAVABLE HOLDER S1 (2) BLUE |
| D764B10740511 | SCHICK AIMRIGHT RING - AUTOCLAVABLE SYSTEM |
| D764B10731101 | SCHICK UNIVERSAL RING - ADHESIVE SYSTEM |
| D764B10730691 | SCHICK ELITE ADHESIVE STARTER KIT SIZE 0 |
| D764B10730681 | SCHICK ELITE / 33 STARTER KIT SIZE 1 |
| D764B10730671 | SCHICK ELITE / 33 STARTER KIT SIZE 2 |
| D764B10730561 | ADHESIVE ENDODONTIC HOLDER SYSTEM (20/PKG) BEIGE |
| D764B10730551 | ADHESIVE PERIAPICAL HOLDERS (50/PKG) YELLOW |
| D764B10730541 | ADHESIVE ANTERIOR HOLDERS (50/PKG) WHITE |
| D764B10730531 | ADHESIVE ENDODONTIC HOLDERS (50/PKG) GREEN |
| D764B10730521 | ADHESIVE BITEWING HOLDER (50/PKG) BLUE |
| D764B10730511 | ADHESIVE BITE TAB HOLDER (50/PKG) RED |
| D764B24030431 | SCHICK ELITE SIZE 0 WITH 3' CABLE ATTACHED |
| D764B24030421 | SCHICK ELITE SIZE 0 WITH 9' CABLE ATTACHED |
| D764B24030411 | SCHICK ELITE SIZE 0 WITH 6' CABLE ATTACHED |
| D764B24030401 | SCHICK ELITE SIZE 0 WITH 18" CABLE ATTACHED |
| D764B24020431 | SCHICK ELITE SIZE 2 WITH 3' CABLE ATTACHED |
| D764B24020421 | SCHICK ELITE SIZE 2 WITH 9' CABLE ATTACHED |
| D764B24020411 | SCHICK ELITE SIZE 2 WITH 6' CABLE ATTACHED |
| D764B24020401 | SCHICK ELITE SIZE 2 WITH 18" CABLE ATTACHED |
| D764B24010421 | SCHICK ELITE SIZE 1 WITH 9' CABLE ATTACHED |
| D764B24010411 | SCHICK ELITE SIZE 1 WITH 6' CABLE ATTACHED |
| D764B24010401 | SCHICK ELITE SIZE 1 WITH 18" CABLE ATTACHED |
| D764B22701000 | SCHICK33/CDR ELITE REMOTE MODULE INTERFACE |
| D764B2270000R1 | SCHICK ELITE REMOTE REPLACEMENT |
| D764B22700001 | SCHICK33/CDR ELITE REMOTE MODULE SHIPPING KIT |
| D764B22501521 | USB REMOTE HS / ELITE CABLE (0.5 METER) |
| D764B22501501 | USB REMOTE HS / ELITE CABLE (5 METER) |
| D764B13172000 | SCHICK ELITE G2 S0 SENSOR |
| D764B13170021 | SCHICK ELITE S0 SENSOR SHIP KIT 3 FT |
| D764B13170011 | SCHICK ELITE S0 SENSOR SHIP KIT 9 FT |
| D764B13170001 | SCHICK ELITE S0 SENSOR SHIP KIT 6 FT |
| D764B13070110 | SCHICK ELITE S0 300 SHEATHS KIT UNIVERSAL SHEATHS SIZE 1 (300/PKG) |
| D764B13070100 | SCHICK ELITE S0 100 SHEATHS KIT UNIVERSAL SHEATHS SIZE 1 (300/PKG) |
| D764B12172000 | SCHICK ELITE G2 S2 SENSOR |
| D764B12170021 | SCHICK ELITE S2 SENSOR SHIP KIT 3 FT |
| D764B12170011 | SCHICK ELITE S2 SENSOR SHIP KIT 9 FT |
| D764B12170001 | SCHICK ELITE S2 SENSOR SHIP KIT 6 FT |
| D764B12091571 | SCHICK REPLACEABLE CABLE 3FT |