Device
LYON ORAL SURGERY CASSETTE
Manufacturer
Peter Brasseler Holdings, LLC
Model: 5031823U0 Catalog: 5031823U0 DI: 08404535019070 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-29 Current Version: 2026-05-07
Description
LYON ORAL SURGERY CASSETTE
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: 256b39fd-3a0a-48af-865f-592bf39e486e
Distribution Status: In Commercial Distribution
DUNS Number: 082080136
Device Count: 1
DM Exempt: Yes
Premarket Exempt: Yes
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08404535019070
Type: Primary
Issuing Agency: GS1
GMDN
Code: 64476
Name: Dental restoration position holder
Definition:
A hand-held manual device intended to be used to hold an indirect restoration (e.g., veneer, overlay, inlay) in place on the surface of the tooth during cementation. It consists of a handle with a restoration holding tip(s); the tip may be disposable. This is a reusable device.
FDA Product Codes
DZN
INSTRUMENTS, DENTAL HAND