FDA.reportPublic FDA data

ceraMotion®

Primary DI
J011250337030
Brand
ceraMotion®
Company
DENTAURUM GmbH & Co.KG
Model
250-337-03
Device description
ceraMotion® One Touch Paste 3D Gingival 5 / dental ceramic material
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K011425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011425000CARMENDentaurum, Inc.2001-06-05EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011250337030PrimaryHIBCC0

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
Special Storage Condition, Specify00No special storage conditions required

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011250321030ceraMotion®250-321-032026-10-23
J011250322030ceraMotion®250-322-032026-10-23
J011250338030ceraMotion®250-338-032026-10-23
J011741049000N.A.741-049-002016-09-15
J011302112000tomas®302-112-002026-09-30
J011302114000tomas®302-114-002026-09-30
J011302212000tomas®302-212-002026-09-30
J011302214000tomas®302-214-002026-09-30
J011250301010ceraMotion®250-301-012026-09-25
J011250306010ceraMotion®250-306-012026-09-25
J011254012040ceraMotion®254-012-042026-09-25
J011254014040ceraMotion®254-014-042026-09-25
J011302150000tomas®302-150-002026-09-04
J011302250000tomas®302-250-002026-09-04
J011520120000Noninium®520-120-002026-09-04
J011621040000Noninium®621-040-002026-09-04
J011621404000Noninium®621-404-002026-09-04
J011621407000Noninium®621-407-002026-09-04
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942075423619BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423626BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423633BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423640BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423657BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423664BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423671BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423688BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423695BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423701BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423718BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423725BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423732BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423749BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
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06942075423787BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
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06942075423831BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
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06942075423855BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
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06942075423886BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423893BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25