FDA.reportPublic FDA data

Erkolen

Primary DI
ERKO5142072
Brand
Erkolen
Company
Erkodent Erich Kopp GmbH
Model
514207
Device description
Erkolen, 0.70 mm, Ø 120 mm, transparent. 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
ERKO5142072PrimaryHIBCC0

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
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
ERKO5232503Erkodur5232502021-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054154160044EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154160068EQULIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154160082EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154160242EQUILIBRATORE C4PEPTAMED SRLKMY2026-08-27
08054154161041EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161058EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161065EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161072EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161096EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161102EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161218EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161225EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161232EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161249EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161256EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161263EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161270EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161294EQUILIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154161300EQUILIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154161317EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161324EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161331EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161348EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161355EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154161362EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154161379EQUILIBRATORE 1.4-SEPTAMED SRLKMY2026-08-27
08054154161386EQUILIBRATORE 1.4-SEPTAMED SRLKMY2026-08-27
08054154161591EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27
08054154161607EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27
08054154161614EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27