FDA.report

3M™ Paradigm™

Primary DI
04054596648111
Brand
3M™ Paradigm™
Company
3M Deutschland GmbH
Model
76974
Catalog number
76974
Device description
3M™ Paradigm™ DeepCure LED Curing Light, 76974, 120 V NA
Published
2020-10-02
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
false

Related Records

Contact Domains

Product Codes

CodeName
EBZActivator, Ultraviolet, For Polymerization

Product Code Classifications

CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054596648111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054596648111040545966481114054596648111

GMDN Terms

TermDefinition
Dental laboratory curing unitA mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
315731711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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