FDA.reportPublic FDA data

ReVeneer Primer

Primary DI
ESDG2322111
Brand
ReVeneer Primer
Company
Schütz Dental GmbH
Model
232211
Device description
ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers.
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESDG2322111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental repair kit, ceramicA packaged collection of devices used for the repair of fractured porcelain veneers. This kit is used by a dentist and may include etching gel or liquid, bonding material, silanization liquid, a polymer-based restorative material (composite) and several other devices. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315830349
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESDG6500101FuturaJet Pink Transparent6500102016-09-12
ESDG6500111FuturaJet Pink Transparent veined6500112016-09-12
ESDG6500121FuturaJet Pink Opaque6500122016-09-12
ESDG6500131FuturaJet Pink6500132016-09-12
ESDG6500141FuturaJet Pink veined6500142016-09-12
ESDG6500151FuturaJet Clear6500152016-09-12
ESDG6500201FuturaJet Pink Transparent6500202016-09-12
ESDG6500211FuturaJet Pink Transparent Veined6500212016-09-12
ESDG6500221FuturaJet Pink Opaque6500222016-09-12
ESDG6500231FuturaJet Pink6500232016-09-12
ESDG6500241FuturaJet Pink veined6500242016-09-12
ESDG6500251FuturaJet Clear6500252016-09-12
ESDG6500501FuturaJet Pink Transparent6500502016-09-12
ESDG6500611FuturaJet Liquid6500612016-09-12
ESDG6500621FuturaJet Liquid6500622016-09-12
ESDG6501101FuturaPress LT Pink Transparent6501102016-09-12
ESDG6501111FuturaPress LT Pink Transparent veined6501112016-09-12
ESDG6501121FuturaPress LT Pink Opaque6501122016-09-12
ESDG6501131FuturaPress LT Pink6501132016-09-12
ESDG6501141FuturaPress LT Pink veined6501142016-09-12

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Primary DI, Brand, Company table
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08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
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00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
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J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
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D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
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