FDA.reportPublic FDA data

NobelPearl Cover Screw Inter-X RP

Primary DI
07640161393141
Brand
NobelPearl Cover Screw Inter-X RP
Company
CeramTec Schweiz GmbH
Model
300699
Catalog number
300699
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
OTC
false
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
07640161393141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161393141076401613931417640161393141

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 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
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
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
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00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
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00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
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00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04