Affordable 1014237

GUDID H66810142371

Pour Powder Lt. Fib Plus 25 lb

Keystone Industries

Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

Primary Device ID	H66810142371
NIH Device Record Key	046c4ea5-c199-4a9e-b1e4-af4671365b33
Commercial Distribution Status	In Commercial Distribution
Brand Name	Affordable
Version Model Number	1014237
Catalog Number	1014237
Company DUNS	073503117
Company Name	Keystone Industries
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com
Phone	+1(800)333-3131
Email	tschwear@keystoneind.com

Device Dimensions

Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound
Weight	25 Pound

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from moisture

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66810142371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983876

FDA Product Code

EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-11-15

On-Brand Devices [Affordable]

H66810142731	Pour P&L Lt. Fib Plus 25 lb / 8 Qts
H66810142371	Pour Powder Lt. Fib Plus 25 lb
H66810142361	Pour Powder Lt. Fib Plus 5 lb
H66810142321	Pour Powder Lt. Fib Orig 25 lb
H66810142311	Pour Powder Lt. Fib Orig 5 llb
H66810142301	Pour Powder Lt. Fib Orig 1 lb
H66810142261	Pour Powder Heavy Veined 5 lb
H66810142201	Pour Powder Clear 1 lb
H66810142111	Pour Denture Liquid Qt

Trademark Results [Affordable]

Mark Image Registration \| Serial	Company Trademark Application Date
AFFORDABLE 98311132 not registered Live/Pending	Ningjin County Jinyixuan Trading Co., Ltd 2023-12-12
AFFORDABLE 97748357 not registered Live/Pending	AFFORDABL INC 2023-01-10
AFFORDABLE 97266595 not registered Live/Pending	Affordable Care, LLC 2022-02-14
AFFORDABLE 97266590 not registered Live/Pending	Affordable Care, LLC 2022-02-14
AFFORDABLE 97266586 not registered Live/Pending	Affordable Care, LLC 2022-02-14
AFFORDABLE 97266578 not registered Live/Pending	Affordable Care, LLC 2022-02-14
AFFORDABLE 97266570 not registered Live/Pending	Affordable Care, LLC 2022-02-14
AFFORDABLE 87872634 5687868 Live/Registered	Ches Younger 2018-04-11
AFFORDABLE 86254989 4648743 Live/Registered	Affiliated Car Rental, L.C. 2014-04-17
AFFORDABLE 76045926 2626823 Dead/Cancelled	Vanmoor, Arthur 2000-05-11
AFFORDABLE 74567901 1966277 Dead/Cancelled	HealthCare COMPARE Corp. 1994-08-31
AFFORDABLE 74055310 1760835 Dead/Cancelled	HealthCare COMPARE Corp. 1990-05-03