Bosworth Ultra Trim 0921808

GUDID H66809218081

Bis-Acryl C&B Cartridge, A3.5

Harry J Bosworth Company

Dental crown/bridge resin, temporary
Primary Device IDH66809218081
NIH Device Record Key8ce86039-c182-4c06-bcfe-b731a2c65636
Commercial Distribution StatusIn Commercial Distribution
Brand NameBosworth Ultra Trim
Version Model Number0921808
Catalog Number0921808
Company DUNS014769301
Company NameHarry J Bosworth Company
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com
Phone+1(800)333-3131
Emailtschwear@keystoneind.com

Device Dimensions

Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter
Weight76 Gram
Total Volume50 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *For best results, refrigerate for storage
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH66809218081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [Bosworth Ultra Trim]

H66809218081Bis-Acryl C&B Cartridge, A3.5
H66809218071Bis-Acryl C&B Cartridge, A2
H66809218061Bis-Acryl C&B Cartridge, A1
H66809218051Bis-Acryl C&B Kit, A3.5
H66809218041Bis-Acryl C&B Kit, A2
H66809213531Bis-Acryl C&B Kit, A1

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