FDA.reportPublic FDA data

QHL75® Curing Light/Spectrum® 800 Curing Light

Primary DI
D0026446571
Brand
QHL75® Curing Light/Spectrum® 800 Curing Light
Company
DENTSPLY INTERNATIONAL INC.
Model
644657
Catalog number
644657
Device description
QHL75® Curing Light/Spectrum® 800 Curing Light Replacement Bulb
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951425000SPECTRUM CURING LIGHT POLYMERIZATION UNITDentsply Intl.1995-05-05EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026446571PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
1
DM exempt
true
Serial number
true

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D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809455602515Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
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08809455602546Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602553Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602560Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
00348783015638Lumira™ LED Curing LightPREMIER DENTAL PRODUCTS COMPANYEBZ2026-04-22
08800017901640CybirdDXM CO., LTDEBZ2026-04-21
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08809455602577Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-21
00348783015492Lumira™ LED Curing LightPREMIER DENTAL PRODUCTS COMPANYEBZ2026-04-14
00810126506191Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
00810126506207Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
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00885797540911FlashMaxRmo, Inc.EBZ2024-08-23
00885797633545FlashMaxRmo, Inc.EBZ2024-08-23
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