Guttacore for WaveOne Gold

Basic Information

• Brand Name: Guttacore for WaveOne Gold
• Primary DI: J003TNSGCWG500MED1
• Version / Model: TNSGCWG500MED
• Catalog Number: TNSGCWG500MED
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• Labeler DUNS: 480538495
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-26
• Public Version: 2
• Public Version Date: 2026-04-17
• Public Version Status: Update
• Public Device Record Key: 899efae8-566c-4109-b8b2-2ac7f0e7f72e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKM	GUTTA-PERCHA	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47751	Warm-bonded endodontic obturation system obturator	A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J003TNSGCWG500MED1	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: up to 86°F