FDA.reportPublic FDA data

ZERAMEX®

Primary DI
07640161390331
Brand
ZERAMEX®
Company
CeramTec Schweiz GmbH
Model
P36530
Catalog number
P36530
Device description
ZERAMEX®P Provisorium RN (inkl. Screw)
Published
2017-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152385000
K163043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152385000Zeramex P6 Dental Implant SystemDentalpoint AG2016-07-27DZE
K163043000Zeramex P6 Dental Implant SystemDentalpoint AG2016-11-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640161390331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161390331076401613903317640161390331

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height1Millimeter
Height7Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41(0)443883636info@zeramex.com

Regulatory Flags#

DUNS number
483229493
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06