FDA.report

Temp Basic

Primary DI
D800TMAD2128
Brand
Temp Basic
Company
ZIRKONZAHN SRL
Model
TMAD2128
Device description
Temp Basic Transpa 95H28
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
POWCrown And Bridge, Long-Term Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
POWCrown And Bridge, Long-Term Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800TMAD2128PrimaryHIBCC0

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
D800DSCL9516BLE0Abro® Basic Multistratum® Bleach 95H16DSCL9516BLE2025-04-04
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D800TMAB0109Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0111Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0113Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0115Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0117Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0119Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0121Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0123Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0125Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0127Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0129Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0209Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0211Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0213Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0215Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0217Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0219Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0221Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0223Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0225Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0227Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0229Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0609Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0611Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0613Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0615Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0617Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0619Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0621Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0623Temp PremiumZIRKONZAHN SRLPOW2018-07-25