CEREC
GUDID E27665429010
CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
CAD/CAM software| Primary Device ID | E27665429010 |
| NIH Device Record Key | 2bfd73bb-445a-4f0e-b86e-f3e8e8ac5088 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CEREC |
| Version Model Number | 6542901 |
| Company DUNS | 340306351 |
| Company Name | SIRONA Dental Systems GmbH |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27665429010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100152
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-10 |
On-Brand Devices [CEREC]
| E27667296150 | Primescan AC with touch pad, steel window sleeve, Special Edition for SDC (Smile Direct Club) |
| E27666927300 | Omnicam AC with touch pad, steel mirror sleeve, only for USA |
| E27666927140 | Primescan AC with touch pad, steel window sleeve, only for USA |
| E27666672370 | CEREC AC 2.0 with Omnicam camera and touch pad |
| E27666672110 | CEREC AC 2.0 with QCC camera and touch pad |
| E27665647150 | CEREC AF Connect with Omnicam |
| E27665647070 | CEREC AI Connect with Omnicam |
| E27665429010 | CEREC AI without CEREC Omnicam |
| E27665428930 | CEREC AF without CEREC Omnicam |
| E27665347910 | CEREC AI with CEREC Omnicam |
| E27665320760 | CEREC AF with CEREC Omnicam |
| E27664315190 | CEREC AC Connect Omnicam |
| E27663718300 | CEREC AC Omnicam |
| E27667188570 | Omnicam AC B-Ware (refurbished) |
Trademark Results [CEREC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CEREC 79035119 3485105 Dead/Cancelled |
Dentsply Sirona, Inc 2006-05-05 |
 CEREC 73745477 1527765 Live/Registered |
BRANDESTINI, MARCO 1988-08-11 |
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