AccessGUDID - DEVICE: Erkoloc-pro blu (ERKO5958302)

GUDID

Device Identifier (DI) Information

Brand Name: Erkoloc-pro blu
Version or Model: 595830
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Erkodent Erich Kopp GmbH

Primary DI Number: ERKO5958302
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654200 *Terms of Use

Device Description: Erkoloc-pro blu, 3.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

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:	Yes
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?
58288	Dental appliance fabrication material, thermoplastic	A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, Prescription
KMY	Positioner, Tooth, Preformed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200125	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 41 and 95 Degrees Fahrenheit
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd550937-05c8-4027-bce7-a2f380bc5bd6
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021