FDA.reportPublic FDA data

iSy® implant analog

Primary DI
04099797021394
Brand
iSy® implant analog
Company
ALTATEC GmbH
Model
P3010.7012
Catalog number
P3010.7012
Device description
P3010.7012 iSy® implant analog
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E219P301070121PreviousHIBCC0
04099797021394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04099797021394040997970213944099797021394

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+4970449445100info.de@camlog.com

Regulatory Flags#

DUNS number
322018193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04099797000726Drill for CT-tubeA2050.2600A2050.26002026-08-17
04099797000733Drill for CT-tubeA2050.2800A2050.28002026-08-17
04099797009200CONELOG® / iSy® Bonding aidC4019.1600C4019.16002026-08-17
04099797009217CONELOG® / iSy® Bonding aidC4019.2000C4019.20002026-08-17
04099797000337CONELOG® SCREW-LINE ImplantC1065.3309C1065.33092026-08-17
04099797000344CONELOG® SCREW-LINE ImplantC1065.3311C1065.33112026-08-17
04099797000351CONELOG® SCREW-LINE ImplantC1065.3313C1065.33132026-08-17
04099797000368CONELOG® SCREW-LINE ImplantC1065.3316C1065.33162026-08-17
04099797000375CONELOG® SCREW-LINE ImplantC1065.3807C1065.38072026-08-17
04099797000382CONELOG® SCREW-LINE ImplantC1065.3809C1065.38092026-08-17
04099797000399CONELOG® SCREW-LINE ImplantC1065.3811C1065.38112026-08-17
04099797000405CONELOG® SCREW-LINE ImplantC1065.3813C1065.38132026-08-17
04099797000412CONELOG® SCREW-LINE ImplantC1065.3816C1065.38162026-08-17
04099797000429CONELOG® SCREW-LINE ImplantC1065.4307C1065.43072026-08-17
04099797000436CONELOG® SCREW-LINE ImplantC1065.4309C1065.43092026-08-17
04099797000443CONELOG® SCREW-LINE ImplantC1065.4311C1065.43112026-08-17
04099797000450CONELOG® SCREW-LINE ImplantC1065.4313C1065.43132026-08-17
04099797000467CONELOG® SCREW-LINE ImplantC1065.4316C1065.43162026-08-17
04099797000474CONELOG® SCREW-LINE ImplantC1065.5007C1065.50072026-08-17
04099797000481CONELOG® SCREW-LINE ImplantC1065.5009C1065.50092026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14