MACRO-LOCK FINISHING DRILL 3

Basic Information

• Brand Name: MACRO-LOCK FINISHING DRILL 3
• Primary DI: ERTDC060100000300000
• Version / Model: 4520123
• Catalog Number: 4520123
• Company Name: RECHERCHES TECHNIQUES DENTAIRES
• Labeler DUNS: 260303508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 2
• Public Version Date: 2023-03-30
• Public Version Status: Update
• Public Device Record Key: 17446b4e-3924-4eec-8a59-fd04935839f1

Device Description

Dental drill

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43311	Pin/post dental drill bit	A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	ERTD4520123012	HIBCC		1	In Commercial Distribution
Package	ERTD4520123V001	HIBCC		1	In Commercial Distribution
Primary	ERTDC060100000300000	HIBCC