Affinity™ Heavy Body RS 120ml 2-Pack 023401

GUDID 00359883002046

VPS Impression Material

DEN-MAT HOLDINGS, LLC

Silicone dental impression material
Primary Device ID00359883002046
NIH Device Record Keyf7204950-9a19-4000-9b00-b19f856c1f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffinity™ Heavy Body RS 120ml 2-Pack
Version Model Number023401
Catalog Number023401
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com

Device Dimensions

Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter
Total Volume120 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883002046 [Unit of Use]
GS100359883002053 [Primary]

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-14

Devices Manufactured by DEN-MAT HOLDINGS, LLC

00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack2025-03-26 Gingival Retraction Solution
00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit2025-03-26 Gingival Retraction Solution
00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack2025-03-24VPS Impression Material
00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack2025-03-24 VPS Impression Material
00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack2025-03-21 Wheel, Polishing Agent
00359883006501 - Clinician's Choice® G5 Sample Pack2025-03-21 Dental coating, tooth-desensitizing, professional
00359883000608 - PowerMix™ Automatic Impression Material Dispenser2025-03-20 Two-component dental material applicator, electric
00359883000615 - PowerMix™ Dynamic Mixing Tips2025-03-20 Dental material mixing nozzle, non-sterile
00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange2025-03-20 Device to engage the matrices and separate teeth

Trademark Results [Affinity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITY
AFFINITY
98533674 not registered Live/Pending
Affinity Petcare, S.A.
2024-05-03
AFFINITY
AFFINITY
98391212 not registered Live/Pending
FloraCraft Corporation
2024-02-05
AFFINITY
AFFINITY
98171032 not registered Live/Pending
Affinity Family Care, LLC
2023-09-08
AFFINITY
AFFINITY
98007525 not registered Live/Pending
Affinity Automotive Products, Inc.
2023-05-22
AFFINITY
AFFINITY
97875538 not registered Live/Pending
Milk Care Co. Inc.
2023-04-06
AFFINITY
AFFINITY
97728207 not registered Live/Pending
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
2022-12-22
AFFINITY
AFFINITY
97652101 not registered Live/Pending
Colin Wayne Bell
2022-10-28
AFFINITY
AFFINITY
97481758 not registered Live/Pending
Waters Technologies Corporation
2022-06-29
AFFINITY
AFFINITY
97352098 not registered Live/Pending
AFFINITY EQUITY PARTNERS LIMITED
2022-04-07
AFFINITY
AFFINITY
97226979 not registered Live/Pending
Melinicoff Associates, LLC
2022-01-19
AFFINITY
AFFINITY
97125444 not registered Live/Pending
REGENXBIO Inc.
2021-11-15
AFFINITY
AFFINITY
97079527 not registered Live/Pending
Locus LP
2021-10-18

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