FDA.reportPublic FDA data

Buffalo Dental

Primary DI
00850043381037
Brand
Buffalo Dental
Company
Buffalo Dental Manufacturing Co., Inc.
Model
Pkg 50 020 Tray & Temp Splint
Catalog number
81660
Device description
Pkg 50 Tray & Temp SplintPkg 200 Tray & Temp Splint
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043381013PackageGS150In Commercial Distribution
00850043381044PackageGS1200In Commercial Distribution
00850043381037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043381013008500433810138500433810130850043381013
00850043381044008500433810448500433810440850043381044
00850043381037008500433810378500433810370850043381037

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
001372853
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850043381273Buffalo Dental Mfg83720837202022-08-05

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Primary DI, Brand, Company table
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