FDA.reportPublic FDA data

ID LIGHTCURE SYSTEM

Primary DI
08809896991032
Brand
ID LIGHTCURE SYSTEM
Company
ID KOREA CO., LTD.
Model
ID NANO STAIN KIT
Device description
This kit contains 16 Bottles (5mL each, Total Volume 80mL):- STAIN A BODY (GTIN CODE : 08809896990622)-STAIN B BODY (GTIN CODE : 08809896990639)- STAIN C BODY (GTIN CODE : 08809896990646)- STAIN D BODY (GTIN CODE : 08809896990653)- STAIN TRANS GREY VIOLET (GTIN CODE : 08809896990707)- STAIN TRANS BLUE (GTIN CODE : 08809896990691)- STAIN ORANGE (GTIN CODE : 08809896990721)- STAIN RED (GTIN CODE : 08809896990745)- STAIN PINK (GTIN CODE : 08809896990738)- STAIN SMOKE BLUE (GTIN CODE : 08809896990752)- STAIN MAMELON BROWN (GTIN CODE : 08809896990677)- STAIN WHITE (GTIN CODE : 08809896990660)- STAIN YELLOW (GTIN CODE : 08809896990714)- STAIN RED BROWN (GTIN CODE : 08809896990684)- STAIN BEIGE OPAQUE (GTIN CODE : 08809896990769)- STAIN PINK OPAQUE (GTIN CODE : 08809896990776)
Published
2026-05-14
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
08809896991032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809896991032088098969910328809896991032

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 Volume80Milliliter

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
08809896991056ID LIGHTCURE SYSTEMID ON-X KIT2026-05-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E235Y00030SHOFU RESIN GLAZESHOFU DENTAL CORPORATIONEBD2026-06-08
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991056ID 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