Model: 6335
Catalog: 6335
DI: E22163351
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
multicolor A3.5 18 mm
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
01651861-06e2-41c5-8eff-923bc929ba07
Distribution Status:
In Commercial Distribution
DUNS Number:
316699578
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
E22163351
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38595
Name: Custom-made dental crown, polymer
Definition:
A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
FDA Product Codes
EBF
Material, Tooth Shade, Resin
Premarket Submissions
Submission Number:
K261357
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
4
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
28
Storage Handling - Storage Handling Type:
Storage Environment Temperature