FDA.reportPublic FDA data

NobelPearl Tapered RP 4.2x8mm

Primary DI
07640161392908
Brand
NobelPearl Tapered RP 4.2x8mm
Company
CeramTec Schweiz GmbH
Model
300755
Catalog number
300755
Device description
Dental Implant
Published
2018-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
07640161392908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161392908076401613929087640161392908

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 Temperature00

Contacts#

Phone, Email table
PhoneEmail
+41443883636mpd.regulatory@ceramtec.de

Regulatory Flags#

DUNS number
483229493
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
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
07640161392502ZERAMEX® WB Transfer Closed TrayWB37512WB375122018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26