AccessGUDID - DEVICE: Admira Fusion 5 (E22162431)

GUDID

Device Identifier (DI) Information

Brand Name: Admira Fusion 5
Version or Model: 6243
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6243
Company Name: VOCO GmbH

Primary DI Number: E22162431
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 13
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Admira Fusion 5 is a light-curing, radiopaque nano-hybrid ORMOCER® restorative material. Admira Fusion 5 contains 83% by weight inorganic fillers and is applied with a dentin enamel bond. It is available in screw syringes and caps for direct application. The simplified shade system of Admira Fusion 5 with its five Cluster-Shades covers all 16 VITA® classical shades.

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:	No
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 [?]
K230877	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
Storage Environment Temperature: between 4 and 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4cd061aa-3e38-42f0-aac4-ed93bc0f0525
Public Version Date: July 27, 2023
Public Version Number: 1
DI Record Publish Date: July 19, 2023