FDA.reportPublic FDA data

Erkoflex

Primary DI
ERKO5812441
Brand
Erkoflex
Company
Erkodent Erich Kopp GmbH
Model
581244
Device description
Erkoflex, 4.00 mm, Ø 120 mm, bright green. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200125000Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH2020-10-28MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERKO5812441PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317654200
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ERKO5142052Erkolen5142052021-09-21
ERKO5142072Erkolen5142072021-09-21
ERKO5142102Erkolen5142102021-09-21
ERKO5212051Erkodur5212052021-09-21
ERKO5212401Erkodur5212402021-09-21
ERKO5215081Erkodur5215082021-09-21
ERKO5215401Erkodur5215402021-09-21
ERKO5219061Erkodur-A15219062021-09-21
ERKO5222061Erkodur-A15222062021-09-21
ERKO5222101Erkodur-A15222102021-09-21
ERKO5222201Erkodur-A15222202021-09-21
ERKO5226061Erkodur-0M15226062021-09-21
ERKO5226101Erkodur-0M15226102021-09-21
ERKO5232053Erkodur5232052021-09-21
ERKO5232083Erkodur5232082021-09-21
ERKO5232103Erkodur5232102021-09-21
ERKO5232153Erkodur5232152021-09-21
ERKO5232203Erkodur5232202021-09-21
ERKO5232303Erkodur5232302021-09-21
ERKO5232403Erkodur5232402021-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
04260670160657dentona vivatempdentona AGMQC2026-06-23
04260670160688optimill memosplintdentona AGMQC2026-06-23
04260670160695optimill memosplintdentona AGMQC2026-06-23
04260670160701optimill memosplintdentona AGMQC2026-06-23
04260670160718optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160725optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160732optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160756optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160664optimill memosplintdentona AGMQC2026-06-22
04260670160671optimill memosplintdentona AGMQC2026-06-22
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06