StoneBite®

Basic Information

• Brand Name: StoneBite®
• Primary DI: E239D5048721
• Version / Model: D504872
• Catalog Number: D504872
• Company Name: Dreve Dentamid GmbH
• Labeler DUNS: 388000846
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 6
• Public Version Date: 2019-11-28
• Public Version Status: Update
• Public Device Record Key: 61f5f631-a1b6-4c88-b2ca-4929ed97659e

Device Description

No.

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38602	Bite registration rim wax	A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E239D5048721	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190571	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius