FDA.reportPublic FDA data

Buffalo Dental Mfg

Primary DI
00850043381198
Brand
Buffalo Dental Mfg
Company
Buffalo Dental Manufacturing Co., Inc.
Model
27550
Catalog number
27550
Device description
Hollenbeck Carver 1/2
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
EIKCarver, Wax, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043381198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043381198008500433811988500433811980850043381198

GMDN Terms#

Term, Definition table
TermDefinition
Dental wax carverA hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. 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
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
00850043381273Buffalo Dental Mfg83720837202022-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB8080TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8090TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8100TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8110TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8120TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8140TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8150TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8050TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8060TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8070TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8160TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8170TBS BASICSACME ENTERPRISE.EIK2026-05-17
00348783010077Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010084Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010091Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010107Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010060Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-27
00348783012309Premier CarversPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-01
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
00840018666016Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-09
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00840018663305Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-29
00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
08800075627551OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03