FDA.reportPublic FDA data

Bosworth Fastray LC

Primary DI
H66809214071
Brand
Bosworth Fastray LC
Company
Harry J Bosworth Company
Model
0921407
Catalog number
0921407
Device description
Fastray LC Standard Kit White
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K991631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991631000FASTRAY LCHarry J. Bosworth Co.1999-07-26ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66809214071PrimaryHIBCC0
H66809214070Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from moisture
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
014769301
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H66809213461Bosworth092134609213462016-09-15
H66809213531Bosworth Ultra Trim092180309218032016-09-15
H66809218041Bosworth Ultra Trim092180409218042016-09-15
H66809218051Bosworth Ultra Trim092180509218052016-09-15
H66809218061Bosworth Ultra Trim092180609218062016-09-15
H66809218071Bosworth Ultra Trim092180709218072016-09-15
H66809218081Bosworth Ultra Trim092180809218082016-09-15
H6681662621Bosworth Duz-All1662621662622023-05-03
H668166261W1Bosworth Duz-All166261W166261W2016-09-15
H6681662101Bosworth Duz-All1662101662102016-09-15
H668166260M1Bosworth Duz-All166260M166260M2016-09-15
H668166261M1Bosworth Duz-All166261M166261M2016-09-15
H6681662631Bosworth Duz-All1662631662632016-09-15
H668166263C1Bosworth Duz-All166263C166263C2016-09-15
H668166263V1Bosworth Duz-All166263V166263V2016-09-15
H6681662641Bosworth Duz-All1662641662642016-09-15
H668166264V1Bosworth Duz-All166264V166264V2016-09-15
H668166267M1Bosworth Duz-All166267M166267M2016-09-15
H6686050011iSmile6050016050012023-02-20
H6684000111iSmile4000114000112023-02-20

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Primary DI, Brand, Company table
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