Model: 6600500
DI: EYET66005000
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f6158733-eb90-4ebe-b7f4-c61e38a5225e
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:
EYET66005000
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38584
Name: Bite registration rim wax, plate
Definition:
A dental material (modelling wax) delivered as prefabricated plates of 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