FDA.reportPublic FDA data

Erkodur-A1

Primary DI
ERKO5219061
Brand
Erkodur-A1
Company
Erkodent Erich Kopp GmbH
Model
521906
Device description
Erkodur-A1, 0.60 mm, Ø 125 mm, tooth colour. 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
ERKO5219061PrimaryHIBCC0

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
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
ERKO5232503Erkodur5232502021-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHMQC2021-11-25
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142102ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5212051ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5212401ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5215081ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5215401ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222061Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222101Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222201Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5226061Erkodur-0M1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5226101Erkodur-0M1Erkodent Erich Kopp GmbHKMY2021-09-21