FDA.report

NobelPearl Impression Coping Closed Tray Inter-X R

Primary DI
07640161393240
Brand
NobelPearl Impression Coping Closed Tray Inter-X R
Company
Dentalpoint AG
Model
300720
Catalog number
300720
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
07640161393240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640161393240076401613932407640161393240

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07640161393769ZERAMEX®XT Rescue-Shell XT REGULARR98100R981002024-05-07
07640161393776ZERAMEX®XT Rescue-Shell XT WIDER98110R981102024-05-07
07640161395077ZERAMEX®XT Rescue-Shell XT SMALLR98120R981202024-05-07
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26