FDA.reportPublic FDA data

ZERAMEX®

Primary DI
07640161390195
Brand
ZERAMEX®
Company
CeramTec Schweiz GmbH
Model
P17512
Catalog number
P17512
Device description
ZERAMEX®P Implant Ø4.8x12mm RN (incl. Healing Cap)
Published
2017-04-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

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

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
07640161390195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161390195076401613901957640161390195

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Outer Diameter4.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
483229493
Device count
1
Lot or batch
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
04260516878418SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878425SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878432SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878449SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878456SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878715SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878722SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878739SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878746SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878753SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879613SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879620SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879637SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879644SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879651SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879668SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879675SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879682SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879699SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879705SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879712SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879729SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879736SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879743SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879750SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879767SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879774SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879781SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879798SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879804SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04