FDA.reportPublic FDA data

Splash®

Primary DI
D813SPD15891
Brand
Splash®
Company
DEN-MAT HOLDINGS, LLC
Model
SPD1589
Catalog number
SPD1589
Device description
SPLASH BLK PK REG MED BRY
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K052090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052090000SPLASH! IMPRESSION MATERIAL DEVICEDiscus Dental, Inc.2005-08-05ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D813SPD15891PrimaryHIBCC0
D813SPD15890Unit of UseHIBCC0

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
Handling Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Do not expose to direct sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D813CR11010Nuance®CR1101CR11012016-09-24
D813CR11020Nuance®CR1102CR11022016-09-24
D813CR11030Nuance®CR1103CR11032016-09-24
D813CR11040Nuance®CR1104CR11042016-09-24
D813CR11060Nuance®CR1106CR11062016-09-24
D813CR11080Nuance®CR1108CR11082016-09-24
D813CR11120Nuance®CR1112CR11122016-09-24
D813CR11210Nuance®CR1121CR11212016-09-24
D813CR11350Nuance®CR1135CR11352016-09-24
D813CR11360Nuance®CR1136CR11362016-09-24
D813CR11370Nuance®CR1137CR11372016-09-24
D813CR11380Nuance®CR1138CR11382016-09-24
D813CR11400Nuance®CR1140CR11402016-09-24
D813CR11420Nuance®CR1142CR11422016-09-24
D813CR11430Nuance®CR1143CR11432016-09-24
D813CR11460Nuance®CR1146CR11462016-09-24
D813CR11550Nuance®CR1155CR11552016-09-24
D813CR12090Nuance®CR1209CR12092016-09-24
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06

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