FDA.reportPublic FDA data

Bosworth Trim II

Primary DI
H6680921100691
Brand
Bosworth Trim II
Company
Harry J Bosworth Company
Model
092110069
Catalog number
092110069
Device description
1 lb PEMA Pwd # 69 (C2)
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H6680921100691PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Pound
Weight454Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from moisture
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
014769301
Device count
1
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998226731Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226748Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774950FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05