FDA.reportPublic FDA data

Acu-Flow Temporary Matrix Material

Primary DI
D811TEMPMATRIXMX2610
Brand
Acu-Flow Temporary Matrix Material
Company
Rainbow Specialty & Health Products Inc
Model
MX261
Device description
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce thestructure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into themouth. This is a single-use device.
Published
2016-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053018000POLY SILOXANE IMPRESSION MATERIALMillennium Dental International, Inc.2005-11-08ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D811TEMPMATRIXMX2610PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
206962040
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D811ACUFLOWMX2610Acu-Flow Temporary Matrix MaterialMX2612016-11-10
D811BALANCEBITEBR8120Balance-Bite Bite RegistrationBR8122016-11-09
D811HARDBESTBITEBR8050BEST-BITE BITE REGISTRATIONBR8052016-08-15
D811HARDBITEBR8010ACU-flow BITE REGISTRATIONBR8012016-08-15
D811HEAVYBODYHB7010ACU-flow HEAVY BODYHB7012016-08-15
D811LIGHTBODYPLUSLB6010ACU-flow LIGHT BODY PLUSLB6012016-08-15
D811LIGHTBODYREGLBR5010LIGHT BODY - REGULAR FLOWLIGHTBODYREGLBR5012016-12-06
D811MEDIUMBODYMB3010ACU-flow MEDIUM BODYMB3012016-08-15
D811PUTTYVPSKITPK9010ACU-flow PUTTY BASE + CATALYST KITPK9012016-08-15
D811RIGIDTRAYRB4010ACU-flow RIGID-TRAYRB4012016-08-15
D811SILICONESR2300ACU-flow THIXOTROPIC SILICONE MATERIALSR2302016-08-15

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