Erkoflex

Basic Information

• Brand Name: Erkoflex
• Primary DI: ERKO5842472
• Version / Model: 584247
• Company Name: Erkodent Erich Kopp GmbH
• Labeler DUNS: 317654200
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-26
• Public Version: 1
• Public Version Date: 2021-09-03
• Public Version Status: New
• Public Device Record Key: 56349349-31d8-421c-8113-f60335396e12

Device Description

Erkoflex, 4.0 mm, Ø 120 mm, night blue. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQC	Mouthguard, Prescription	Unknown		U
KMY	Positioner, Tooth, Preformed	Dental	872.5525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ERKO5842472	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K200125	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius