FDA.reportPublic FDA data

Adper™ Scotchbond™

Primary DI
50605861014255
Brand
Adper™ Scotchbond™
Company
3M COMPANY
Model
7545S
Catalog number
7545S
Device description
3M™ ESPE™ Adper™ Scotchbond™ Multi-Purpose Plus Adhesive System Intro Kit, 7545S
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
50605861014255PackageGS110In Commercial Distribution
30605861014251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060586101425550605861014255
3060586101425130605861014251

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
1
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
false
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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106058610773823M™ Filtek™4867A14867A12026-05-08
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Primary DI, Brand, Company table
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J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
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