FDA.reportPublic FDA data

ZZ BASE DE-DE-WMSM-L15 3.8 - 4.1 (White Metal Scanmarker L15 with Scre

Primary DI
D800ZBED15732L15
Brand
ZZ BASE DE-DE-WMSM-L15 3.8 - 4.1 (White Metal Scanmarker L15 with Scre
Company
ZIRKONZAHN SRL
Model
ZBED15732L15
Device description
Compatible with Dentegris Dental Implant System Dentegris implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
Published
2021-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
D800ZBED15732L15PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA 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 includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+390474066660info@zirkonzahn.com

Regulatory Flags#

DUNS number
564251911
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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D800FMAA06030Colour Liquid B1 (20 ml)FMAA06032026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)FMAA07032026-05-28
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D800FMAA09030Colour Liquid B4 (20 ml)FMAA09032026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)FMAA10032026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)FMAA11032026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)FMAA12032026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)FMAA13032026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)FMAA14032026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)FMAA15032026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)FMAA16032026-05-28
D800FMAA17030Set Colour Liquid (20 ml)FMAA17032026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)FMAA19032026-05-28
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D800FMAA31020Colour Liquid Prettau A1 (100 ml)FMAA31022026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)FMAA31032026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)FMAA32022026-05-28

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