FDA.reportPublic FDA data

PROPHYLACTIC STRIP

Primary DI
07897990308031
Brand
PROPHYLACTIC STRIP
Company
TDV DENTAL LTDA
Model
0009010101
Catalog number
0009010101
Device description
Prophylactic Strips - 10 Units (EN)
Published
2025-03-04
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
ELAInstrument, Hand, Calculus Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990308031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990308031078979903080317897990308031

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, single-useA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900580358
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
07897990300103PROPHY BRUSHES501300100250130010022026-05-18
07897990300110PROPHY BRUSHES501300100350130010032026-05-18
07897990300127PROPHY BRUSHES501300100450130010042026-05-18
07897990300219PROPHY BRUSHES501300100550130010052026-05-18
07897990300233PROPHY BRUSHES501300100650130010062026-05-18
07897990300264PROPHY BRUSHES501300100750130010072026-05-18
07897990300271PROPHY BRUSHES501300100850130010082026-05-18
07897990300288PROPHY BRUSHES501300100950130010092026-05-18
07897990300295PROPHY BRUSHES501300101050130010102026-05-18
07897990300325PROPHY BRUSHES501300101150130010112026-05-18
07897990300332PROPHY BRUSHES501300101250130010122026-05-18
07897990301070PROPHY BRUSHES501300101350130010132026-05-18
07897990301087PROPHY BRUSHES501300101450130010142026-05-18
07897990301094PROPHY BRUSHES501300101550130010152026-05-18
07897990301100PROPHY BRUSHES501300101650130010162026-05-18
07897990301117PROPHY BRUSHES501300101750130010172026-05-18
07897990301124PROPHY BRUSHES501300101850130010182026-05-18
07897990301131PROPHY BRUSHES501300101950130010192026-05-18
07897990301148PROPHY BRUSHES501300102050130010202026-05-18
07897990301155PRAXIS POLISHERS501202101250120210122026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810132809446House Brand DentistryFrontier Dental Supply IncELA2026-02-10
00810132809439House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809453House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809460House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00047701001813DentekDenTek Oral Care, Inc.ELA2024-06-19
ESAM1820001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1825001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1826001STOMA®Storz am Mark GmbHELA2020-08-27
00840018624139NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625068NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625235NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625242NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
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00840018625266NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
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00840018616851NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616868NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
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00840018616882NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616899NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616905NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616912NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616929NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616936NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616943NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616950NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
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00840018616981NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616998NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12