Device
WAXING INST SE PK THOMAS 1
Manufacturer
PREMIER DENTAL PRODUCTS COMPANY
Model: 1004383 DI: 00348783010077 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
WAXING INST SE PK THOMAS 1
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: fb3875ca-1e8c-46d8-bdc2-74626543e842
Distribution Status: In Commercial Distribution
DUNS Number: 014789663
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: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00348783010077
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35794
Name: Dental wax carver
Definition:
A hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.
FDA Product Codes
EIK
Carver, Wax, Dental