FDA.reportPublic FDA data

JUVORA™ Dental Disc

Primary DI
05055948200406
Brand
JUVORA™ Dental Disc
Company
JUVORA LIMITED
Model
540020
Device description
JUVORA™ Dental Disc, 540020, US-DD-98-22-02
Published
2018-06-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132725000
K160918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132725000JUVORA DENTQAL DISCJuvora2014-01-23EBI
K160918000JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora2017-02-13EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055948200406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055948200406050559482004065055948200406

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height22Millimeter
Outer Diameter98Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401253898000info@juvoradental.com

Regulatory Flags#

DUNS number
218501322
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055948229308Ceramill PEEK by JUVORA™ Oyster White7604032019-01-21
05055948229315Ceramill PEEK by JUVORA™ Oyster White7604042019-01-21
05055948229599CERAMILL PEEK by JUVORA™ Natural7604092018-08-10
05055948229605CERAMILL PEEK by JUVORA™ Natural7604102018-08-10
05055948229612JUVORA™ Oyster White Dental Disc 5401032019-01-21
05055948229629JUVORA™ Oyster White Dental Disc 5401042019-01-21
05055948229636JUVORA™ Oyster White Dental Disc 5401052019-01-21
05055948229643JUVORA™ Oyster White Dental Disc 5401062019-01-21
05055948229650JUVORA™ Oyster White Dental Disc 5401072019-01-21
05055948229711JUVORA™ Natural Dental Disc 5401132019-01-21
05055948229728JUVORA™ Natural Dental Disc 5401142019-01-21
05055948229735JUVORA™ Natural Dental Disc 5401152019-01-21
05055948229742JUVORA™ Natural Dental Disc 5401162019-01-21
05055948229759JUVORA™ Natural Dental Disc 5401172019-01-21
05055948229254Ceramill PEEK by JUVORA™ Oyster White7603932019-01-21
05055948229292Ceramill PEEK by JUVORA™ Oyster White7603942019-01-21
05055948229575CERAMILL PEEK by JUVORA™ Natural7604052018-08-10
05055948229582CERAMILL PEEK by JUVORA™ Natural7604062018-08-10
05055948229667JUVORA™ Oyster White Dental Disc 5401082019-01-21
05055948229674JUVORA™ Oyster White Dental Disc 5401092019-01-21

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