FDA.reportPublic FDA data

Loop™

Primary DI
00810038093604
Brand
Loop™
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
CLL02
Catalog number
CLL02
Device description
Loaner: Loop™ LED Curing Light Handpiece
Published
2023-04-22
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
EBZActivator, Ultraviolet, For Polymerization

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200775000LOOP LED Curing Light SystemGarrison Dental Solutions, LLC2020-08-14EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810038093604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810038093604008100380936048100380936040810038093604

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.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
8884370032mmorris@garrisondental.com

Regulatory Flags#

DUNS number
057647005
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810038091464LOOP™ LED Curing LightCLK01-RCLK01-R2025-02-27
00810038091471LOOP™ LED Curing LightCLK01-WCLK01-W2025-02-27
00810038091488LOOP™ LED Curing LightCLK01-SCLK01-S2025-02-27
00810038091129Quad Matrix System™QPLQPL2025-02-16
00810038091136Quad Matrix System™QK4-MQK4-M2025-02-16
00810038091143Quad Matrix System™QK4QK42025-02-16
00810038091150Quad Matrix System™QBLQBL2025-02-16
00810038091167Quad Matrix System™QORQOR2025-02-16
00810038091174Quad Matrix System™QGRQGR2025-02-16
00810038091181Quad Matrix System™QPL-MQPL-M2025-02-16
00810038091198Quad Matrix System™QBL-MQBL-M2025-02-16
00810038091204Quad Matrix System™QOR-MQOR-M2025-02-16
00810038091211Quad Matrix System™QGR-MQGR-M2025-02-16
00810038091228Quad Matrix System™QR01QR012025-02-16
00810038091235Quad Matrix System™Q400Q4002025-02-16
00810038091242Quad Matrix System™Q500Q5002025-02-16
00810038091259Quad Matrix System™Q400L-1Q400L-12025-02-16
00810038091266Quad Matrix System™Q400R-1Q400R-12025-02-16
00810038091273Quad Matrix System™Q500L-1Q500L-12025-02-16
00810038091280Quad Matrix System™Q500R-1Q500R-12025-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006522211493673M™ Ortholux™3M UNITEK CORPORATIONEBZ2026-04-25
006522211493743M™ Ortholux™3M UNITEK CORPORATIONEBZ2026-04-25
006522211493813M™ Ortholux™3M UNITEK CORPORATIONEBZ2026-04-25
08809455602515Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602522Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602539Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
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
08809455602508Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-21
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
J014660164550Starlight proKulzer GmbHEBZ2026-01-28
07615208476217Bluephase EasyCureIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2024-09-25
00885797472557FlashMaxRmo, Inc.EBZ2024-08-23
00885797472564FlashMaxRmo, Inc.EBZ2024-08-23
00885797540911FlashMaxRmo, Inc.EBZ2024-08-23
00885797633545FlashMaxRmo, Inc.EBZ2024-08-23
D6620708507352Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
D6620708540002Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
D6620708540182Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
E22190021Caps WarmerVOCO GmbHEBZ2024-05-07
07615208458787Bluephase PowerCureIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2024-03-25
07615208461206Bluephase G4IVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2023-06-14
07630392901437Coltolux ComfortDent4You AGEBZ2023-02-01
07630392901444Coltolux ComfortDent4You AGEBZ2023-02-01