DEVICE: CEREC Optispray (E27662038192)

Device Identifier (DI) Information

CEREC Optispray
6203819
In Commercial Distribution

SIRONA Dental Systems GmbH
E27662038192
HIBCC

25
340306351 *Terms of Use
Special nozzle CEREC Optispray 25 pcs.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 impression tray, single-use A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ELW Material, Impression
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K080882 000
No CLOSE

Sterilization

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

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

497924a7-1ee9-4644-b728-9d6397a0e5d1
July 06, 2018
3
September 16, 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: E27662037440 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+4962511670
contact@dentsplysirona.com
CLOSE