FDA.report

NobelPearl Tapered Surgery Kit

Primary DI
07640161393653
Brand
NobelPearl Tapered Surgery Kit
Company
Dentalpoint AG
Model
300770
Catalog number
300770
Device description
Tools
Published
2018-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640161393653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640161393653076401613936537640161393653

GMDN Terms

TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable 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
false
Premarket exempt
true
HCT/P
false
Kit
true
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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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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