FDA.reportPublic FDA data

ZERAMEX® XT Implant Ø3.5x12mm SB (incl. Healing Cap)

Primary DI
07640161394025
Brand
ZERAMEX® XT Implant Ø3.5x12mm SB (incl. Healing Cap)
Company
CeramTec Schweiz GmbH
Model
XT15512
Catalog number
XT15512
Device description
Dental Implant
Published
2020-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640161394025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161394025076401613940257640161394025

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483229493
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640161394599NobelPearl™ Abutment Straight Inter-X NP 1mm3006633006632022-01-13
07640161394629NobelPearl™ Cover Screw Inter-X NP3006983006982022-01-13
07640161394636NobelPearl™ Healing Abutment Inter-X NP 3.5x3mm3007023007022022-01-13
07640161394643NobelPearl™ Healing Abutment Inter-X NP 3.5x4mm3007053007052022-01-13
07640161394650NobelPearl™ Temporary Abutment Inter-X NP3007133007132022-01-13
07640161394322NobelPearl Tapered NP 3.5x8mm3007523007522021-10-26
07640161394339NobelPearl Tapered NP 3.5x10mm3007533007532021-10-26
07640161394346NobelPearl Tapered NP 3.5x12mm3007543007542021-10-26
07640161395114NobelPearl Tapered RP 4.2x8mm3007553007552021-10-26
07640161392908NobelPearl Tapered RP 4.2x8mm3007553007552018-11-30
07640161393110NobelPearl Definitive Clinical Screw Inter-X RP/WP3006913006912018-11-30
07640161393127NobelPearl Temporary Clinical Screw Inter-X RP/WP3006933006932018-11-30
07640161393141NobelPearl Cover Screw Inter-X RP3006993006992018-11-30
07640161393165NobelPearl Healing Abutment Inter-X RP 4.2x3mm3007083007082018-11-30
07640161393189NobelPearl Healing Abutment Inter-X WP 5.5x3mm3007103007102018-11-30
07640161393202NobelPearl Temporary Abutment Inter-X RP3007143007142018-11-30
07640161393219NobelPearl Temporary Abutment Inter-X WP3007153007152018-11-30
07640161391451ZERADRILL™ W12 (WIDE 12mm)T37612T376122018-11-30
07640161391840ZERAMEX® XT Implant Ø5.5x8mm WB (incl. Healing Cap)XT17508XT175082018-11-30
07640161392403ZERAMEX® RB Transfer Closed TrayRB36512RB365122018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711456prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780126Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29