AccessGUDID - DEVICE: Admira Protect (E22116501)

GUDID

Device Identifier (DI) Information

Brand Name: Admira Protect
Version or Model: 1650
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1650
Company Name: VOCO GmbH

Primary DI Number: E22116501
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible with a curing light. Futurabond DC achieves the same adhesive properties as total-etch preparations without seperate etching of the tooth substance. Moisture-tolerant. Durable marginal integrity. Easy and fast application - one-coat, one-cure technique. contains fluorides. No refrigerated storage needed. Ideal for paediatric use.

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?
34771	Dental unfilled resin sealant/coating	A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	Sealant, Pit And Fissure, And Conditioner

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061823	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: 8e49cde9-db2a-41ca-9d48-5e7db3e6bba9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016