DEVICE: Grandio (E22118401)

Device Identifier (DI) Information

Grandio
1840
In Commercial Distribution
1840
VOCO GmbH
E22118401
HIBCC

20
316699578 *Terms of Use
Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EBF Material, Tooth Shade, Resin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051867 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 23 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

97472040-012a-41c7-9473-e8d942374a02
July 06, 2018
3
August 31, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: E22118400 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
999-999-9999
xxx@xx.xx
CLOSE