FDA.report

Ascent PX Replacement Wand

Primary DI
00872320001469
Brand
Ascent PX Replacement Wand
Company
CAO GROUP, INC.
Model
001-00052
Catalog number
001-00052
Device description
Replacement wand (light probe) for the Ascent PX curing light.
Published
2016-11-10
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
00872320001469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320001469008723200014698723200014690872320001469

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.

Sterilization Methods

Method

Contacts

PhoneEmail
877-236-4408info@caogroup.com

Regulatory Flags

DUNS number
102422578
Device count
1
DM exempt
true
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
false

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