FDA.reportPublic FDA data

Prevest C&B Permanent

Primary DI
D967180080
Brand
Prevest C&B Permanent
Company
PREVEST DENPRO LIMITED
Model
1000g 18008
Published
2025-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233273000C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited2024-11-27EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D967180080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Regulatory Flags#

DUNS number
859546940
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D967410010Rotoflex Gold files triangular cross section 21mm pack of six410012026-04-29
D967410020Rotoflex Gold files triangular cross section 25mm pack of six410022026-04-29
D967410030Rotoflex Gold files triangular cross section 31mm pack of six410032026-04-29
D967410040Rotoflex Gold files triangular cross section 17/0421mm pack of six410042026-04-29
D967410050Rotoflex Gold files triangular cross section 17/0425mm pack of six410052026-04-29
D967410060Rotoflex Gold files triangular cross section 20/0421mm pack of six410062026-04-29
D967410070Rotoflex Gold files triangular cross section 20/0425mm pack of six410072026-04-29
D967410080Rotoflex Gold files triangular cross section 25/0421mm pack of six410082026-04-29
D967410090Rotoflex Gold files triangular cross section 25/0425mm pack of six410092026-04-29
D967410100Rotoflex Gold files triangular cross section 30/0421mm pack of six410102026-04-29
D967410110Rotoflex Gold files triangular cross section 30/0425mm pack of six410112026-04-29
D967410120Rotoflex Gold files triangular cross section 35/0421mm pack of six410122026-04-29
D967410130Rotoflex Gold files triangular cross section 35/0425mm pack of six410132026-04-29
D967410140Rotoflex Gold files triangular cross section 40/0421mm pack of six410142026-04-29
D967410150Rotoflex Gold files triangular cross section 40/0425mm pack of six410152026-04-29
D967410160Rotoflex Gold files triangular cross section 20/0621mm pack of six410162026-04-29
D967410170Rotoflex Gold files triangular cross section 20/0625mm pack of six410172026-04-29
D967410180Rotoflex Gold files triangular cross section 25/0621mm pack of six410182026-04-29
D967410190Rotoflex Gold files triangular cross section 25/0625mm pack of six410192026-04-29
D967410200Rotoflex Gold files triangular cross section 30/0621mm pack of six410202026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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