FDA.report

3M™ Ketac™ Molar Quick Aplicap™

Primary DI
04035077029537
Brand
3M™ Ketac™ Molar Quick Aplicap™
Company
3M Deutschland GmbH
Model
56361
Device description
3M™ Ketac™ Molar Quick Aplicap™ Glass Ionomer Restorative Material, 56361, A2 Shade
Published
2023-10-25
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
true

Related Records

Contact Domains

Product Codes

CodeName
EBFMaterial, tooth shade, resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04064035106423PrimaryGS10
04064035106447PrimaryGS10
04035077029537Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04064035106423040640351064234064035106423
04064035106447040640351064474064035106447
04035077029537040350770295374035077029537

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
20
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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040545969528673M™ Kerramax Care™PRD500-050PRD500-0502026-01-29
040545969528983M™ Kerramax Care™PRD500-050-B50PRD500-050-B502026-01-29
040640350845093M™ Kerramax Care™PRD500-050-B550PRD500-050-B5502026-01-29
040545969529423M™ Kerramax Care™PRD500-065PRD500-0652026-01-29
040545969529733M™ Kerramax Care™PRD500-100PRD500-1002026-01-29
040640350845613M™ Kerramax Care™PRD500-100-B550PRD500-100-B5502026-01-29
040545969530243M™ Kerramax Care™PRD500-1174PRD500-11742026-01-29
040545969530793M™ Kerramax Care™PRD500-1175PRD500-11752026-01-29
040545969531093M™ Kerramax Care™PRD500-1176PRD500-11762026-01-29
040545969531303M™ Kerramax Care™PRD500-1177PRD500-11772026-01-29
040545969531613M™ Kerramax Care™PRD500-120PRD500-1202026-01-29
040545969531923M™ Kerramax Care™PRD500-120-B50PRD500-120-B502026-01-29
040545969532223M™ Kerramax Care™PRD500-240PRD500-2402026-01-29
040545969532533M™ Kerramax Care™PRD500-240-B30PRD500-240-B302026-01-29
040545969533143M™ Kerramax Care™PRD500-380-B10PRD500-380-B102026-01-29
040545969533453M™ Kerramax Care™PRD500-380-B30PRD500-380-B302026-01-29
040545969533763M™ Kerramax Care™PRD500-600-B10PRD500-600-B102026-01-29
04035077009386Clinpro™ Glycine Prophy Powder67008670082017-08-04

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