FDA.reportPublic FDA data

Light Guide

Primary DI
00841396101700
Brand
Light Guide
Company
Kerr Corporation
Model
921676
Catalog number
921676
Device description
Final, Assembly; Light Guide; 8mm to 4mm
Published
2016-08-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841396101700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841396101700008413961017008413961017000841396101700

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
199354556
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19
00195062145278ZenFlex CM818-36052026-02-19
00195062145285ZenFlex CM818-36062026-02-19
00195062145292ZenFlex CM818-36072026-02-19
00195062145308ZenFlex CM818-36082026-02-19
00195062145315ZenFlex CM818-36092026-02-19
00195062145322ZenFlex CM818-36102026-02-19
00195062145339ZenFlex CM818-36112026-02-19
00195062145346ZenFlex CM818-36122026-02-19
00195062145353ZenFlex CM818-36132026-02-19
00195062145360ZenFlex CM818-36142026-02-19
00195062145377ZenFlex CM818-36152026-02-19
00195062145384ZenFlex CM818-36162026-02-19
00195062145391ZenFlex CM818-36172026-02-19
00195062145407ZenFlex CM818-36182026-02-19
00195062145759ZenFlex CM818-35912026-02-19
00195062145766ZenFlex CM818-35922026-02-19
00195062145773ZenFlex CM818-36912026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506191Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
00810126506207Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
J014660164550Starlight proKulzer GmbHEBZ2026-01-28
J014660573650Starlight proKulzer GmbHEBZ2026-01-28
J014660968300Starlight proKulzer GmbHEBZ2026-01-28
J014660969290Starlight proKulzer GmbHEBZ2026-01-28
J014660971690Starlight proKulzer GmbHEBZ2026-01-28
J014660971700Starlight proKulzer GmbHEBZ2026-01-28
00883205044372Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044389Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044396Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
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00883205044419Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044426Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
D0029444001SmartLite® Pro Modular LED Curing LightDENTSPLY INTERNATIONAL INC.EBZ2025-09-09
00883205035561Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-21
00883205041906VALOULTRADENT PRODUCTS, INC.EBZ2025-08-21
00883205032997VALOULTRADENT PRODUCTS, INC.EBZ2025-08-20
00883205042873Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042880Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
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00883205042903Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042910Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042927Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042934Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043269Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043276Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043283Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043290Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043306Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14