AccessGUDID - DEVICE: ROEKO RoekoSeal Automix (E1653491020)

GUDID

Device Identifier (DI) Information

Brand Name: ROEKO RoekoSeal Automix
Version or Model: Refill pack Dual-barrel syringe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 349102
Company Name: Coltène/Whaledent GmbH + Co. KG

Primary DI Number: E1653491020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315494443 *Terms of Use

Device Description: No description.

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?
36095	Endodontic filling/sealing material	A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KIF	Resin, Root Canal Filling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983037	000

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 18 and 24 Degrees Celsius
Storage Environment Temperature: between 64 and 75 Degrees Fahrenheit
Special Storage Condition, Specify: keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb4a720b-b9d0-4149-9c0d-35a337650f55
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 18, 2016