FDA.reportPublic FDA data

LOOP™ LED Curing Light

Primary DI
00810038091464
Brand
LOOP™ LED Curing Light
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
CLK01-R
Catalog number
CLK01-R
Device description
LOOP™ LED Curing Light-Sample
Published
2025-02-27
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
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810038091464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810038091464008100380914648100380914640810038091464

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
888-437-0032gds@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
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
00810038091334Quad Matrix System™Q-KHF-40Q-KHF-402025-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25