FDA.reportPublic FDA data

NobelPearl Healing Abutment Inter-X WP 5.5x4mm

Primary DI
07640161393196
Brand
NobelPearl Healing Abutment Inter-X WP 5.5x4mm
Company
CeramTec Schweiz GmbH
Model
300712
Catalog number
300712
Device description
Prosthetics
Published
2018-11-30
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
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

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

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
07640161393196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161393196076401613931967640161393196

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.

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
+41443883636mpd.regulatory@ceramtec.de

Regulatory Flags#

DUNS number
483229493
Device count
1
DM exempt
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
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
07640161393578NobelPearl Implant Driver Inter-X RP/WP 25mm3006893006892018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075201041I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201058I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201065I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201072I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075202048Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208613Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208620Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208637Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208644Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208651Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208668Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208675Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208682Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208699Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208705Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208712Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208729Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
00842092187661PreatPreat CorporationNHA2026-04-30
00842092187685PreatPreat CorporationNHA2026-04-30
00842092187708PreatPreat CorporationNHA2026-04-30
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2025-10-31
00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
00842092125656PreatPreat CorporationNHA2022-10-24
00842092126257PreatPreat CorporationNHA2022-10-24
00842092127001AstraPreat CorporationNHA2022-10-24
00842092127049AstraPreat CorporationNHA2022-10-24
00842092127087AstraPreat CorporationNHA2022-10-24
00842092127094AstraPreat CorporationNHA2022-10-24