FDA.reportPublic FDA data

Futar

Primary DI
E217119291
Brand
Futar
Company
Kettenbach GmbH & Co. KG
Model
11929
Catalog number
11929
Device description
Futar Clear Normal pack
Published
2026-04-02
Public version status
New
Distribution status
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081120000FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALSKettenbach GmbH & Co. KG2008-05-01ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E217119291PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4927747050info@kettenbach.de

Regulatory Flags#

DUNS number
316803246
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E217135901Visalys CemCore Try In Paste13590135902019-11-25
E217135911Visalys CemCore Try In Paste13591135912019-11-25
E217135921Visalys CemCore Try In Paste13592135922019-11-25
E217135931Visalys CemCore Try In Paste13593135932019-11-25
E217135941Visalys CemCore Try In Paste13594135942019-11-25
E217149401ProphyProtect149402026-06-08
E217150601Visalys Bulk Fill150602026-03-05
E217150611Visalys Bulk Fill150612026-03-05
E217150621Visalys Bulk Fill150622026-03-05
E217150681Visalys Bulk150682026-03-05
E217150761Visalys BioCeramic Block15076150762026-01-09
E217150751Visalys BioCeramic Block150752026-01-19
E217150851Visalys BioCeramic Block15085150852026-01-19
E217150701Visalys BioCeramic Block15070150702026-01-09
E217150711Visalys BioCeramic Block15071150712026-01-09
E217150721Visalys BioCeramic Block15072150722026-01-09
E217150731Visalys BioCeramic Block15073150732026-01-09
E217150741Visalys BioCeramic Block15074150742026-01-09
E217150801Visalys BioCeramic Block15080150802026-01-09
E217150811Visalys BioCeramic Block15081150812026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412304789Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313163Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313170Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313187Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06970402679941Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06970402679958Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
00197998040627Solventum™ Paradigm™Solventum US LLCELW2026-10-24
00197998040733Solventum™ Paradigm™Solventum US LLCELW2026-10-24
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20