Device
Reusable Luxating Instrument, Mesial Serrated Edge 4.5 mm, non-sterile
Manufacturer
MELPEX BEAUTY INSTRUMENTS
Model: Mesial Serrated Edge 4.5 mm Catalog: 325-781 DI: 08961104679245 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
Reusable Luxating Instrument, Mesial Serrated Edge 4.5 mm, non-sterile
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: 54e79fee-e07a-4175-b488-b6cf7bf244bd
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: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Device ID: 08961104679245
Type: Primary
Issuing Agency: GS1
GMDN
Code: 16480
Name: Dental elevator, tooth/root
Definition:
A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.
FDA Product Codes
EMJ
Elevator, Surgical, Dental
Device Sizes
Device Size - Size Text: Tip Width 4.5 mm
Device Size - Size Type: Device Size Text, specify