DEVICE: OrthoEasy (EFOR1101A2310)

Device Identifier (DI) Information

OrthoEasy
1101A2310
In Commercial Distribution
1101A2310
Forestadent Bernhard Förster GmbH
EFOR1101A2310
HIBCC

1
316074384 *Terms of Use
The device is intended to provide a fix anchorage point for attachment of orthodontic appliance to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
55772 Organic solvent metabolite IVD, kit, liquid chromatography
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple metabolites/biomarkers associated with occupational or environmental exposure to volatile organic solvents (e.g., benzene, styrene, toluene, xylene) in a clinical specimen, using a liquid chromatography method. Compounds detected typically include phenol, cresol, hippuric acid, methylhippuric acid, mandelic acid, muconic acid, and/or phenylglyoxylic acid; detection of polycyclic aromatic hydrocarbon (PAH) metabolites is not included.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OAT Implant, Endosseous, Orthodontic
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 10 Millimeter
CLOSE

Device Record Status

bba74f4e-86d6-4c32-ad44-aa750fffaba6
October 31, 2018
4
September 16, 2015
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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE