AccessGUDID - DEVICE: Ionoseal (E22113261)

GUDID

Device Identifier (DI) Information

Brand Name: Ionoseal
Version or Model: 1326
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1326
Company Name: VOCO GmbH

Primary DI Number: E22113261
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Dual-curing universal composite-based luting system. For all materials (metal, composite inlays and ceramic, also zirconium dioxide). Bubble-free perfect mixing. Direct application. Excellent adhesion to dentine, enamel and to metals. Special one-step Ceramic bond for optimal adhesion to porcelain. Radiopaque. Available in three shadese. Try-In pastes simplify shade selection before cementation. All-in-one set.

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?
16704	Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJK	Liner, Cavity, Calcium Hydroxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 6d9ac9f8-2c72-465b-a146-6418b0ece09e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2016