| Primary Device ID | D764B10711021 |
| NIH Device Record Key | 16edf43e-8e67-4e5f-b090-261f7bfe3233 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CDR |
| Version Model Number | B1071102 |
| Company DUNS | 078613913 |
| Company Name | SIRONA DENTAL, INC. |
| Device Count | 1 |
| 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 | D764B10711021 [Primary] |
| EAP | Unit, X-Ray, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
[D764B10711021]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-03 |
| Device Publish Date | 2016-09-09 |
| D764B24041001 | CENTER AIMING RING* |
| D764B1104050R1 | CDR WIRED SIZE 1 REPLACEMENT |
| D764B10720061 | PHOENIX ANTERIOR HOLDER SIZE 2 (25/PKG) |
| D764B10720031 | PHOENIX HORIZONTAL BITEWING HOLDER SIZE 2 (25/PKG) |
| D764B10711021 | PHOENIX HOLDER SET SIZE 1 |
| D764B24042001 | POSTERIOR AIMING RING* |
| D764B10730611 | UNIVERSAL STARTER KIT - SIZE 2 |
| D764B10730601 | UNIVERSAL STARTER KIT - SIZE 1 |
| D764B10720071 | PHOENIX VERTICAL BITEWING HOLDER SIZE 2 (25/PKG) |
| D764B10720051 | PHOENIX VERTICAL BITE TAB SIZE 2 (25/PKG) |
| D764B10720041 | PHOENIX PERIAPICAL HOLDER SIZE 2 (25/PKG) |
| D764B10720021 | PHOENIX HORIZONTAL BITE TAB SIZE 2 (25/PKG) |
| D764B10720011 | PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 2 (25/PKG) |
| D764B10711031 | STANDARD HOLDER SET - SIZE 0 |
| D764B10711001 | PHOENIX HOLDER SET SIZE 2 - SENSOR WITH SERIAL # ABOVE 604999 |
| D764B10710601 | PHOENIX SNAP-A-RAY |
| D764B10710451 | PHOENIX VERTICAL BITE TAB SIZE 0 (25/PKG) |
| D764B10710421 | PHOENIX HORIZONTAL BITE TAB SIZE 0 (25/PKG) |
| D764B10710411 | PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 0 (25/PKG) |
| D764B10710271 | PHOENIX VERTICAL BITEWING HOLDER SIZE 1 (25/PKG) |
| D764B10710261 | PHOENIX ANTERIOR HOLDER SIZE 1 (25/PKG) |
| D764B10710251 | PHOENIX VERTICAL BITE TAB SIZE 1 (25/PKG) |
| D764B10710241 | PHOENIX PERIAPICAL HOLDER SIZE 1 (25/PKG) |
| D764B10710231 | PHOENIX HORIZONTAL BITEWING HOLDER SIZE 1 (25/PKG) |
| D764B10710221 | PHOENIX HORIZONTAL BITE TAB SIZE 1 (25/PKG) |
| D764B10710211 | PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 1 (25/PKG) |
| D764B10710071 | PHOENIX VERTICAL BITEWING HOLDER SIZE 2 (25/PKG) |
| D764B10710061 | PHOENIX ANTERIOR HOLDER SIZE 2 (25/PKG) |
| D764B10710051 | PHOENIX VERTICAL BITE TAB SIZE 2 (25/PKG) |
| D764B10710041 | PHOENIX PERIAPICAL HOLDER SIZE 2 (25/PKG) |
| D764B10710031 | PHOENIX HORIZONTAL BITEWING HOLDER SIZE 2 (25/PKG) |
| D764B10710021 | PHOENIX HORIZONTAL BITE TAB SIZE 2 (25/PKG) |
| D764B10710011 | PHOENIX ENDODONTIC HOLDER W/HEMOSTAT TAB SIZE 2 (25/PKG) |
| D764B01220001 | POSTERIOR ARM* |
| D764B01210001 | BITEWING ARM* |
| D764B01200001 | ANTERIOR ARM* |
| D764B22501000 | CDR USB 2 INTERFACE ASSY |
| D764B2250000R1 | CDR REMOTE HS REPLACEMENT |
| D764B22500001 | USB REMOTE HS SHIP KIT |
| D764B13031000 | CDR SENSOR S0 |
| D764B1303050R1 | CDR WIRED SIZE 0 REPLACEMENT |
| D764B13030501 | SENSOR SIZE 0 |
| D764B12041000 | CDR SENSOR S2 |
| D764B1204050R1 | CDR WIRED SIZE 2 REPLACEMENT |
| D764B12040501 | SENSOR SIZE 2 |
| D764B11041000 | CDR SENSOR S1 |
| D764B11040501 | SENSOR SIZE 1 |