Renamel® Microhybrid

Basic Information

• Brand Name: Renamel® Microhybrid
• Primary DI: EDEL6062B01
• Version / Model: 6062B0
• Catalog Number: 6062B0
• Company Name: DeltaMed GmbH
• Labeler DUNS: 344805101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-05-31
• Public Version: 1
• Public Version Date: 2023-06-08
• Public Version Status: New
• Public Device Record Key: ae80eb3b-3457-469b-b403-03c4daaf1989

Device Description

Renamel® Microhybrid Body B-Zero, 10 Compules

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	EDEL6062B00	HIBCC
Primary	EDEL6062B01	HIBCC
Previous	D7796062B01	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K222435	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: avoid direct sunlight
• Type: Storage Environment Temperature
• Temperature Range: 4 – 24 Degrees Celsius