FDA.reportPublic FDA data

Ceramill PEEK by JUVORA™ Oyster White

Primary DI
05055948229292
Brand
Ceramill PEEK by JUVORA™ Oyster White
Company
JUVORA LIMITED
Model
760394
Device description
CERAMILL PEEK by JUVORA™ 760394, Oyster White 71x20 – 1 unit
Published
2019-01-21
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
K181331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181331000JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster WhiteJuvora, Ltd.2018-12-21EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055948229292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055948229292050559482292925055948229292

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
Height20Millimeter
Outer Diameter101Millimeter

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
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
05055948229681JUVORA™ Oyster White Dental Disc 5401102019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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