FDA.reportPublic FDA data

Monet Curing Laser Small Glasses

Primary DI
00872320005641
Brand
Monet Curing Laser Small Glasses
Company
CAO GROUP, INC.
Model
001-00108
Device description
Small laser protective glasses for use with the Monet Curing Laser.
Published
2020-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QNFLaser Activator For Polymerization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNFLaser Activator For PolymerizationDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00872320005641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320005641008723200056418723200056410872320005641

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding goggles/spectaclesA personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-999-2635support@amdlasers.com

Regulatory Flags#

DUNS number
102422578
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00872320005825LEAP Cavity Cleansing Solution006-002722026-04-10
00872320006440Picasso Pro Diode Laser002-004602026-04-10
00872320006617Picasso Pro Pre-initiated Laser Tip, Variety Pack002-004802026-04-10
00872320006846LEAP Laser Delivery Tip050832026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mm053792026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mm051932026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mm053802026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mm051942026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, Straight052212026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, Curved052222026-04-10
00872320006761Monet + Curing Laser001-001232026-02-10
00872320004477Ultimate Contour Mini005-000362019-09-06
00872320003364Pilot Diode Laser 600um Tip030932016-11-10
00872320003418Pilot Straight Tip006682016-11-10
00872320003425Pilot 60° Tip006692016-11-10
00872320003456Pilot Diode Laser030922016-11-10
00872320006457Acuity Direct X-Ray Photon Detection005-001232024-02-19
00872320006464Acuity Direct X-Ray Photon Detection005-002142024-02-19
00872320000127BlissBond Intro Kit006-00044006-000442016-11-10
00872320000141BlissEtch Intro Kit006-00029006-000292016-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00872320006761Monet + Curing LaserCAO GROUP, INC.QNF2026-02-10
07649988072420OdneCure TipOdne AGQNF2024-02-02
07649988072406OdneCure TipOdne AGQNF2024-02-02
07649988156694OdneCureOdne AGQNF2024-02-01
00872320005610Monet Curing LaserCAO GROUP, INC.QNF2020-12-14
00872320005627Monet Curing Laser Battery PackCAO GROUP, INC.QNF2020-12-14
00872320005634Monet Curing Laser Large GlassesCAO GROUP, INC.QNF2020-12-14
00872320005665Monet Curing Laser Charging StandCAO GROUP, INC.QNF2020-12-14
00872320005948Monet Curing Laser Barrier SleeveCAO GROUP, INC.QNF2020-12-14