Device
This kit contains 3 Syringes (6g each, Total Weight 18g):
Manufacturer
ID KOREA CO., LTD.
ID KOREA CO., LTD.
Model: ID CROWN KIT INTRO
DI: 08809896991063
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
This kit contains 3 Syringes (6g each, Total Weight 18g):
- CROWN FLOW A1 (GTIN CODE : 08809896990394)
- CROWN FLOW A2 (GTIN CODE : 08809896990400)
- CROWN FLOW A3 (GTIN CODE : 08809896990417)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f54e8ed8-1947-4ca8-a1c0-09f2c94ec0f5
Distribution Status:
In Commercial Distribution
DUNS Number:
694785677
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08809896991063
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34771
Name: Dental unfilled resin sealant/coating
Definition:
A 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.
FDA Product Codes
EBD
Coating, Filling Material, Resin
Premarket Submissions
Submission Number:
K250804
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gram
Device Size - Size - @attributes - Value:
18
Device Size - Size Type:
Weight
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
5
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature