FDA.report

TITANIT 5 106H16

Primary DI
D800MEAL10616
Brand
TITANIT 5 106H16
Company
ZIRKONZAHN SRL
Model
MEAL10616
Device description
Content: 1 piece Height: 16 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
Published
2022-07-20
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
false

Related Records

Product Codes

CodeName
EJHALLOY, METAL, BASE

Product Code Classifications

CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800MEAL10616PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bridge, metal-ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods

Method

Contacts

PhoneEmail
+390474066660info@zirkonzahn.com

Regulatory Flags

DUNS number
564251911
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
false

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D800DSCL9516C030Abro® Basic Multistratum® C3 95H16DSCL9516C032025-04-04
D800DSCL9516C040Abro® Basic Multistratum® C4 95H16DSCL9516C042025-04-04
D800DSCL9516D020Abro® Basic Multistratum® D2 95H16DSCL9516D022025-04-04
D800DSCL9516D030Abro® Basic Multistratum® D3 95H16DSCL9516D032025-04-04
D800DSCL9516D040Abro® Basic Multistratum® D4 95H16DSCL9516D042025-04-04
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