FDA.reportPublic FDA data

NobelPearl Tapered RP 4.2x14mm

Primary DI
07640161395145
Brand
NobelPearl Tapered RP 4.2x14mm
Company
CeramTec Schweiz GmbH
Model
300758
Catalog number
300758
Device description
Dental Implant
Published
2021-10-26
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
K180184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180184000Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG2018-11-16NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640161395145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161395145076401613951457640161395145

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep out of sunlight
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41443883630pascal.wettstein@zeramex.com

Regulatory Flags#

DUNS number
483229493
Device count
1
DM exempt
true
Kit
true
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
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
07640161392502ZERAMEX® WB Transfer Closed TrayWB37512WB375122018-11-30
07640161393028NobelPearl 15 Abutment Inter-X WP 1mm3006713006712018-11-30
07640161393134NobelPearl Lab Screw Inter-X RP/WP3006953006952018-11-30
07640161393158NobelPearl Cover Screw Inter-X WP3007013007012018-11-30
07640161393172NobelPearl Healing Abutment Inter-X RP 4.2x4mm3007093007092018-11-30
07640161393196NobelPearl Healing Abutment Inter-X WP 5.5x4mm3007123007122018-11-30
07640161393257NobelPearl Impression Coping Closed Tray Inter-X WP3007213007212018-11-30
07640161393264NobelPearl Impression Coping Closed Tray Inter-X RP long3007233007232018-11-30
07640161393301NobelPearl Implant Replica Inter-X RP3007293007292018-11-30
07640161393325NobelPearl Round Bur 2mm3007313007312018-11-30
07640161393356NobelPearl Tapered Drill NP 3.5x10mm3007343007342018-11-30
07640161393363NobelPearl Tapered Drill NP 3.5x12mm3007353007352018-11-30
07640161393424NobelPearl Tapered Drill RP 4.2x12mm3007423007422018-11-30
07640161393455NobelPearl Tapered Dense Bone Drill RP 4.2mm3007453007452018-11-30
07640161393493NobelPearl Tapered Screw Tap WP 5.5mm3007493007492018-11-30
07640161393523NobelPearl Tapered Depth/Direction Indicators3007513007512018-11-30
07640161393530NobelPearl Screwdriver RP/WP 19mm3006613006612018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
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08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
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08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
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08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
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08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04