FDA.report

Elipar™ S10

Primary DI
04035077006804
Brand
Elipar™ S10
Company
3M Deutschland GmbH
Model
76967
Catalog number
76967
Device description
3M™ ESPE™ Elipar™ S10 Turbo Light Guide 8 Mm Refill, 76967
Published
2017-08-04
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

Related Records

Contact Domains

Product Codes

CodeName
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035077006804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035077006804040350770068044035077006804

GMDN Terms

TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Device Sizes

TypeValueUnit
Outer Diameter8Millimeter

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
false
Manufacturing date on label
false
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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