FDA.reportPublic FDA data

ID LIGHTCURE SYSTEM

Primary DI
08809896991056
Brand
ID LIGHTCURE SYSTEM
Company
ID KOREA CO., LTD.
Model
ID ON-X KIT
Device description
This kit contains 2 major types of products (total 6 items):(1) 3 Syringes (6g each, Total Weight 18g):- GUM FLOW PINK (GTIN CODE : 08809896990189)- GUM FLOW LIGHT PINK (GTIN CODE : 08809896990196)- GUM FLOW DARK PINK (GTIN CODE : 08809896990202)(2) 3 Bottles (5mL each, Total Volume 15mL):- STAIN A BODY (GTIN CODE : 08809896990622)- STAIN SMOKE BLUE (GTIN CODE : 08809896990752)- STAIN MAMELON BROWN (GTIN CODE : 08809896990677)
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBDCoating, Filling Material, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250804000ID LIGHT CURE SYSTEMId Korea Co., Ltd.2025-06-04EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809896991056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809896991056088098969910568809896991056

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter
Weight18Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+8207047793000idkorea7@gmail.com

Regulatory Flags#

DUNS number
694785677
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809896990288ID LIGHTCURE SYSTEMID GUM KIT INTRO2026-05-15
08809896991063ID LIGHTCURE SYSTEMID CROWN KIT INTRO2026-05-15
08809896990172ID LIGHTCURE SYSTEMGUM FLOW GRANATE2026-05-14
08809896990189ID LIGHTCURE SYSTEMGUM FLOW PINK2026-05-14
08809896990196ID LIGHTCURE SYSTEMGUM FLOW LIGHT PINK2026-05-14
08809896990202ID LIGHTCURE SYSTEMGUM FLOW DARK PINK2026-05-14
08809896990219ID LIGHTCURE SYSTEMGUM FLOW PEACH2026-05-14
08809896990226ID LIGHTCURE SYSTEMGUM FLOW RED ORANGE2026-05-14
08809896990233ID LIGHTCURE SYSTEMGUM FLOW RUBY2026-05-14
08809896990240ID LIGHTCURE SYSTEMGUM FLOW CHOCOLATE2026-05-14
08809896990257ID LIGHTCURE SYSTEMGUM FLOW VIOLET2026-05-14
08809896990264ID LIGHTCURE SYSTEMGUM FLOW NAVY2026-05-14
08809896990271ID LIGHTCURE SYSTEMGUM FLOW GREY2026-05-14
08809896990295ID LIGHTCURE SYSTEMID GUM KIT2026-05-14
08809896990387ID LIGHTCURE SYSTEMCROWN FLOW OPAQUE2026-05-14
08809896990400ID LIGHTCURE SYSTEMCROWN FLOW A22026-05-14
08809896990417ID LIGHTCURE SYSTEMCROWN FLOW A32026-05-14
08809896990424ID LIGHTCURE SYSTEMCROWN FLOW B12026-05-14
08809896990431ID LIGHTCURE SYSTEMCROWN FLOW B22026-05-14
08809896990448ID LIGHTCURE SYSTEMCROWN FLOW C22026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991063ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
00810184450030RodinPac-Dent, Inc.EBD2026-05-15
08809896990172ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990189ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990196ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990202ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990219ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990226ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990233ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990240ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990257ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990264ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990271ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990295ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990387ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990400ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990417ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990424ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990431ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990448ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990455ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990462ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990479ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990486ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990493ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990509ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990516ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990523ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990530ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14