FDA.reportPublic FDA data

CEREC

Primary DI
E27667188570
Brand
CEREC
Company
SIRONA Dental Systems GmbH
Model
6718857
Device description
Omnicam AC B-Ware (refurbished)
Published
2020-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous
PNPDental Abutment Design Software For Dental Laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2
PNPDental Abutment Design Software For Dental LaboratoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27667188570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, chairsideAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E27668907712Single use sleeve Primescan Box68907712026-09-22
E27667732580Sidexis 467732582022-12-20
E27667737871Sidexis 467737872022-12-20
E27667755841Sidexis 467755842022-12-20
E27667755921Sidexis 467755922022-12-20
E27666182630Sidexis 466182632021-12-23
E27662291290SIDEXIS XG62291292016-09-10
E27664565320SIDEXIS 464565322016-09-10
E27666164650Sidexis 466164652017-04-20
E27666632770Sidexis 466632772018-08-27
E27668234260Primevision 3D682342667585982026-02-13
E27668234830Primevision 3D68234832026-04-30
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27660437020IMPLANT 20:160437022016-09-10
E27668082030Primescan 268082032025-11-21
E27668325910TiBase683259168325912025-10-28
E27668326410TiBase683264168326412025-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118608TITAN IMPLANTS INCTITAN IMPLANT INCNHA2026-10-12
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
08809984989040S-PlantIDIS CO.,LTDNHA2026-10-07
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
08809984970895S-PlantIDIS CO.,LTDNHA2026-10-07
08809984981518S-PlantI Dis Co., Ltd.NHA2026-10-07
D7702764233TRANSGINGIVAL HEALING CAP H3MMSWEDEN & MARTINA SPANHA2026-10-07
D7702764243TRANSGINGIVAL HEALING CAP H5MMSWEDEN & MARTINA SPANHA2026-10-07
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06