FDA.reportPublic FDA data

Rebilda Form

Primary DI
E22114071
Brand
Rebilda Form
Company
VOCO GmbH
Model
1407
Published
2017-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHQCusp, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHQCusp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22114071PrimaryHIBCC0
E2211407Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E22122661VOCO Profluorid Varnish + BioMin226622662026-05-06
E22122671VOCO Profluorid Varnish + BioMin226722672026-05-06
E22122681VOCO Profluorid Varnish + BioMin226822682026-05-06
E22122691VOCO Profluorid Varnish + BioMin226922692026-05-06
E22122701VOCO Profluorid Varnish + BioMin227022702026-05-06
E22122711VOCO Profluorid Varnish + BioMin227122712026-05-06
E22122721VOCO Profluorid Varnish + BioMin227222722026-05-06
E22122731VOCO Profluorid Varnish + BioMin227322732026-05-06
E22122741VOCO Profluorid Varnish + BioMin227422742026-05-06
E22122761VOCO Profluorid Varnish + BioMin227622762026-05-06
E22122771VOCO Profluorid Varnish + BioMin227722772026-05-06
E22122781VOCO Profluorid Varnish + BioMin227822782026-05-06
E22122791VOCO Profluorid Varnish + BioMin227922792026-05-06
E22163141Grandio disc multicolor631463142026-04-30
E22163151Grandio disc multicolor631563152026-04-30
E22163161Grandio disc multicolor631663162026-04-30
E22163171Grandio disc multicolor631763172026-04-30
E22163181Grandio disc multicolor631863182026-04-30
E22163191Grandio disc multicolor631963192026-04-30
E22163231Grandio disc multicolor632363232026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E22117711Rebilda PostVOCO GmbHEHQ2019-06-06
E22114081Rebilda FormVOCO GmbHEHQ2017-11-26
E22114091Rebilda FormVOCO GmbHEHQ2017-11-26
E22117821Rebilda PostVOCO GmbHEHQ2017-11-26
E22119721Rebilda Post GTVOCO GmbHEHQ2017-11-24