DEVICE: Cavex Individual Trays lowers plain (E241BL0560)

Device Identifier (DI) Information

Cavex Individual Trays lowers plain
BL056
In Commercial Distribution
BL056
Cavex Holland B.V.
E241BL0560
HIBCC

1
419980156 *Terms of Use
Dental Wax
CLOSE

Device Characteristics

MR Safe
No
No
No
No
Yes
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?
34808 Dental base plate
A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EEA Plate, Base, Shellac
CLOSE

FDA Premarket Submission

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

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 1 pcs
CLOSE

Device Record Status

c0e76401-08c2-46c7-800b-a84d8bba087c
March 29, 2018
2
July 07, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+31(0)235307700
r.woortman@cavex.nl
CLOSE