Model: Perforated
Catalog: 21-414
DI: 08961104622654
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Impression Tray Set 10 pcs Perforated
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
54d89093-52be-4d9f-b428-9f7c3f31abe2
Distribution Status:
In Commercial Distribution
DUNS Number:
645674404
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
08961104622654
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35850
Name: Dental impression tray, reusable
Definition:
A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device.
FDA Product Codes
EHY
Tray, Impression, Preformed