FDA.report

NobelPearl Lab Screw Inter-X RP/WP

Primary DI
07640161393134
Brand
NobelPearl Lab Screw Inter-X RP/WP
Company
Dentalpoint AG
Model
300695
Catalog number
300695
Device description
Acessories
Published
2018-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640161393134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640161393134076401613931347640161393134

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

PhoneEmail
+41443883630pascal.wettstein@zeramex.com

Regulatory Flags

DUNS number
483229493
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07640161396401CERALOG PL Implant, Ø 3.8 L 9HP1040.3809HP1040.38092024-04-29
07640161396432CERALOG PL Implant, Ø 3.8 L 11HP1040.3811HP1040.38112024-04-29
07640161396449CERALOG PL Implant, Ø 3.8 L 13HP1040.3813HP1040.38132024-04-29
07640161396456CERALOG PL Implant, Ø 4.3 L 9HP1040.4309HP1040.43092024-04-29
07640161396463CERALOG PL Implant,Ø 4.3 L 11HP1040.4311HP1040.43112024-04-29
07640161396470CERALOG PL Implant, Ø 4.3 L 13HP1040.4313HP1040.43132024-04-29
07640161396487CERALOG PL Implant, Ø 5.0 L 9HP1040.5009HP1040.50092024-04-29
07640161396494CERALOG PL Implant, Ø 5.0 L 11HP1040.5011HP1040.50112024-04-29
07640161396500CERALOG PL Implant, Ø 5.0 L 13HP1040.5013HP1040.50132024-04-29
07640161396517CERALOG® PL Abutment straight Ø 3.8 mm, GH 1.0 mmHP2251.3810HP2251.38102024-04-29
07640161396524CERALOG® PL Abutment straight Ø 3.8 mm, GH 2.0 mmHP2251.3820HP2251.38202024-04-29
07640161396531CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mmHP2252.3810HP2252.38102024-04-29
07640161396548CERALOG® PL Bonding base crown, Ø 3.8 mm, GH 0.8 mmHP2246.3808HP2246.38082024-04-29
07640161396555CERALOG® PL Bonding base bridge, Ø 3.8 mm, GH 0.8 mmHP2247.3808HP2247.38082024-04-29
07640161396562CERALOG® PL Abutment straight Ø 4.3 mm, GH 1.0 mmHP2251.4310HP2251.43102024-04-29
07640161396579CERALOG® PL Abutment straight Ø 4.3 mm, GH 2.0 mmHP2251.4320HP2251.43202024-04-29
07640161396586CERALOG® PL Abutment 15° angled, Ø 4.3 mm, GH 1.0 mmHP2252.4310HP2252.43102024-04-29

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