FDA.reportPublic FDA data

Dowell Dental Products, Inc

Primary DI
D961MS103904
Brand
Dowell Dental Products, Inc
Company
Dowell Dental Products, Inc
Model
MS1039
Device description
Bone Packer Condenser
Published
2022-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKGCondenser, Amalgam And Foil, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D961MS103904PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, medicated, reusableA collection of various dental/surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9092973646support@dowelldentalproducts.com

Regulatory Flags#

DUNS number
004041234
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D961MS1010B0Dowell Dental Products, IncMS1010B2022-08-30
D961M50040Dowell Dental Products, IncM50042022-08-23
D961M50060Dowell Dental Products, IncM50062022-08-23
D961M50070Dowell Dental Products, IncM50072022-08-23
D961MS10050Dowell Dental Products, IncMS10052022-08-23
D961MS10260Dowell Dental Products, IncMS10262022-08-23
D961MS1112S0Dowell Dental Products, IncMS1112S2022-08-23
D961MS12330Dowell Dental Products, IncMS12332022-08-23
D961MS12590Dowell Dental Products, IncMS12592022-08-23
D961MS12800Dowell Dental Products, IncMS12802022-08-23
D961MS12890Dowell Dental Products, IncMS12892022-08-23
D961MS5010B0Dowell Dental Products, IncMS5010B2022-08-23
D961S10280Dowell Dental Products, INc S10282022-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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G149TBSB4190TBS BASICSACME ENTERPRISE.EKG2026-05-20
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07898506843541QuinelatoSchobell Industrial LtdaEKG2022-12-08
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10889950019129HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKG2020-11-12