FDA.reportPublic FDA data

NobelPearl Implant Driver Inter-X RP/WP 20mm

Primary DI
07640161393561
Brand
NobelPearl Implant Driver Inter-X RP/WP 20mm
Company
Dentalpoint AG
Model
300688
Catalog number
300688
Device description
Tools
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
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640161393561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161393561076401613935617640161393561

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental burA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable 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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41443883630pascal.wettstein@zeramex.com

Regulatory Flags#

DUNS number
483229493
Device count
1
DM exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
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