FDA.reportPublic FDA data

Micron Superior Capsules

Primary DI
D9673001030
Brand
Micron Superior Capsules
Company
PREVEST DENPRO LIMITED
Model
Box of 10
Catalog number
30010-3
Published
2023-01-03
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200555000Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)Prevest Denpro Limited2021-05-13EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9673001030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Regulatory Flags#

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

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