FDA.report

SINTERNIT 95H10

Primary DI
D800MEAS9510
Brand
SINTERNIT 95H10
Company
ZIRKONZAHN SRL
Model
MEAS9510
Device description
Content: 1 piece Height: 10 mm Sinternit (cobalt-chrome alloy) for the production of single crowns, bridges, bars and telescopic crowns. It is suitable for monolithic restorations as well as structures of up to 14 units for veneering with ceramics. Info: our Sintermetall has a new name: Sinternit. 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
D800MEAS9510PrimaryHIBCC0

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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