Model: 6140100
DI: EYET61401000
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
02294f1b-690b-405c-8ce8-a415126742a6
Distribution Status:
In Commercial Distribution
DUNS Number:
324001916
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
EYET61401000
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38602
Name: Bite registration rim wax
Definition:
A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.
FDA Product Codes
EGD
Wax, Dental, Intraoral