AccessGUDID - DEVICE: Renamel® Microfill (EDEL6151D30)

GUDID

Device Identifier (DI) Information

Brand Name: Renamel® Microfill
Version or Model: 6151D3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6151D3
Company Name: DeltaMed GmbH

Primary DI Number: EDEL6151D30
Issuing Agency: HIBCC
Commercial Distribution End Date: October 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 344805101 *Terms of Use
Previous DI: D7796151D30

Device Description: Renamel® Microfill Enamel Body D3, Syringe 2g

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172707	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: avoid direct sunlight
Storage Environment Temperature: between 4 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 27f34904-545d-41ad-8862-64c53d6316c1
Public Version Date: November 06, 2024
Public Version Number: 2
DI Record Publish Date: May 31, 2023