FDA.reportPublic FDA data

Buffalo Dental Mfg

Primary DI
00850043381402
Brand
Buffalo Dental Mfg
Company
Buffalo Dental Manufacturing Co., Inc.
Model
26811
Catalog number
26811
Device description
Carrier Millenium 34 Steel
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKICarrier, Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043381402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043381402008500433814028500433814020850043381402

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam carrierA hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
001372853
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043381037Buffalo DentalPkg 50 020 Tray & Temp Splint816602026-04-10
00850043381570Buffalo DentalPkg 12 080 EVA, Pkg 25 080 EVA, Pkg 100 080 EVA, P62804,62806, 62830, 628002026-04-10
00850043381587Buffalo DentalPkg 12 118 EVA, Pkg 25 118 EVA, Pkg 100 118 EVA, P62815, 62816, 62805, 628102026-04-10
00850043381082Buffalo Dental1 Sheet Bleach tray EVA2026-03-25
00850043381129Buffalo Dental1 Sheet 160 EVA2026-03-25
00850043381532Buffalo Dental Mfg586058602023-08-11
00850043381549Buffalo Dental MfgCustbur2023-08-11
00850043381525Buffalo Dental TW2-AATW2-AA2022-09-08
00850043381150Buffalo Dental Mfg27610276102022-08-05
00850043381167Buffalo Dental Mfg27600276002022-08-05
00850043381174Buffalo Dental Mfg44550445502022-08-05
00850043381181Buffalo Dental Mfg27503275032022-08-05
00850043381198Buffalo Dental Mfg27550275502022-08-05
00850043381204Buffalo Dental Mfg27560275602022-08-05
00850043381211Buffalo Dental Mfg27581275812022-08-05
00850043381228Buffalo Dental Mfg27590275902022-08-05
00850043381235Buffalo Dental Mfg78300783002022-08-05
00850043381242Buffalo Dental Mfg78320783202022-08-05
00850043381259Buffalo Dental Mfg83660836602022-08-05
00850043381266Buffalo Dental Mfg83601836012022-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB8180TBS BASICSACME ENTERPRISE.EKI2026-05-18
G149TBSB8190TBS BASICSACME ENTERPRISE.EKI2026-05-18
00371347023428Advance Dental ProductsThe Atlanta Dental Supply CompanyEKI2026-04-14
00348783008753Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-18
00348783008760Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-17
08800075627698OSUNG MNDOSUNG MND Co., Ltd.EKI2025-11-03
07898078650134SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078657423SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078659427EdgeUtopia RRM Dispensing GunAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
00813677023063PDT, Inc.PDT, INC.EKI2024-07-02
00813677023087PDT, Inc.PDT, INC.EKI2024-07-02
00813677023070PDT, Inc.PDT, INC.EKI2024-07-01
00813677023124PDT, Inc.PDT, INC.EKI2024-06-27
00813677024978PDT, Inc.PDT, INC.EKI2024-06-27
00840105223160ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223177ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223184ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223191ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223207ZOLL DENTALZoll-DentalEKI2024-05-31
D105SKU1312510SurgiMac Surgimac LLCEKI2024-05-08
D105SKU131257H02SurgiMac Surgimac LLCEKI2024-04-22
D105SKU131257H13SurgiMac Surgimac LLCEKI2024-04-22
10889950142407Amalgam Carrier, Reg/MiniHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142414Amalgam Carrier, Reg/LrgHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142421Amalgam Carrier, Reg/JumboHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142438Amalgam WellHU-FRIEDY MFG. CO., LLCEKI2024-04-02
D105SKU1312550SurgiMac Surgimac LLCEKI2024-03-18
D105SKU1312551SurgiMac Surgimac LLCEKI2024-03-18
08800075626325OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-23
08800075603531OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21