FDA.reportPublic FDA data

Creation Willi Geller

Primary DI
09010782027349
Brand
Creation Willi Geller
Company
KLEMA Dentalprodukte GmbH
Model
652013
Catalog number
652013
Device description
ZI-F/ Dentine D-C4
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043201000WILLI GELLER CREATION ZI PORCELAINJensen Industries, Inc.2005-01-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010782027349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010782027349090107820273499010782027349

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-323-2164Info-NorthAmerica@Creation-Willigeller.com

Regulatory Flags#

DUNS number
301063590
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09010782003268Creation Willi Geller0012050012052023-03-29
09010782003275Creation Willi Geller0012060012062023-03-29
09010782003282Creation Willi Geller0012070012072023-03-29
09010782008485Creation Willi Geller6205056205052023-02-24
09010782026144Creation Willi Geller6200516200512023-02-24
09010782026175Creation Willi Geller6200606200602023-02-24
09010782026199Creation Willi Geller6200746200742023-02-24
09010782026212Creation Willi Geller6201026201022023-02-24
09010782026229Creation Willi Geller6201036201032023-02-24
09010782026236Creation Willi Geller6201046201042023-02-24
09010782026243Creation Willi Geller6201056201052023-02-24
09010782026250Creation Willi Geller6201066201062023-02-24
09010782026267Creation Willi Geller6201076201072023-02-24
09010782026274Creation Willi Geller6201086201082023-02-24
09010782026281Creation Willi Geller6201206201202023-02-24
09010782026298Creation Willi Geller6201216201212023-02-24
09010782026304Creation Willi Geller6201226201222023-02-24
09010782026328Creation Willi Geller6201246201242023-02-24
09010782026380Creation Willi Geller6201316201312023-02-24
09010782026397Creation Willi Geller6201326201322023-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941382296862Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296916Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296923Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
08800118648406RazorU&C International Co.,LtdEIH2026-09-04
08800118648413RazorU&C International Co.,LtdEIH2026-09-04
08800118648420RazorU&C International Co.,LtdEIH2026-09-04
08800118648437RazorU&C International Co.,LtdEIH2026-09-04
08800118648444RazorU&C International Co.,LtdEIH2026-09-04
08800118648451RazorU&C International Co.,LtdEIH2026-09-04
08800118648468RazorU&C International Co.,LtdEIH2026-09-04
08800118648475RazorU&C International Co.,LtdEIH2026-09-04
08800118648482RazorU&C International Co.,LtdEIH2026-09-04
08800118648499RazorU&C International Co.,LtdEIH2026-09-04
08800118648505RazorU&C International Co.,LtdEIH2026-09-04
08800118648512RazorU&C International Co.,LtdEIH2026-09-04
08800118648529RazorU&C International Co.,LtdEIH2026-09-04
08800118648536RazorU&C International Co.,LtdEIH2026-09-04
08800118648543RazorU&C International Co.,LtdEIH2026-09-04
08800118648550RazorU&C International Co.,LtdEIH2026-09-04
08800118648567RazorU&C International Co.,LtdEIH2026-09-04
08800118648574RazorU&C International Co.,LtdEIH2026-09-04
08800118648581RazorU&C International Co.,LtdEIH2026-09-04
08800118648598RazorU&C International Co.,LtdEIH2026-09-04
08800118648604RazorU&C International Co.,LtdEIH2026-09-04
08800118648611RazorU&C International Co.,LtdEIH2026-09-04
08800118648628RazorU&C International Co.,LtdEIH2026-09-04