FDA.report

Temp Basic

Primary DI
D800TMAD6212
Brand
Temp Basic
Company
ZIRKONZAHN SRL
Model
TMAD6212
Device description
Temp Basic A2-B2 98H12 with step
Published
2018-07-25
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
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800TMAD6212PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, 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

Regulatory Flags

DUNS number
564251911
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D800DSCL9516B040Abro® Basic Multistratum® B4 95H16DSCL9516B042025-04-04
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D800DSCL9516C010Abro® Basic Multistratum® C1 95H16DSCL9516C012025-04-04
D800DSCL9516C020Abro® Basic Multistratum® C2 95H16DSCL9516C022025-04-04
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
D800DSCL98S16A010Abro® Basic Multistratum® A1 98H16 with stepDSCL98S16A012025-04-04

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