FDA.reportPublic FDA data

Twist™ Disposable Prophy Angles Brush

Primary DI
10732224003358
Brand
Twist™ Disposable Prophy Angles Brush
Company
CROSSTEX INTERNATIONAL, INC.
Model
TPATB
Device description
Prophy Angles Brush, Tapered Brush
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFAHandpiece, belt and/or gear driven, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFAHandpiece, Belt And/Or Gear Driven, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973062000TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEMedidenta Intl., Inc.1997-10-09EFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224003356PackageGS14In Commercial Distribution
10732224003358PrimaryGS10
00732224003351Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400335650732224003356
1073222400335810732224003358
00732224003351007322240033517322240033510732224003351

GMDN Terms#

Term, Definition table
TermDefinition
Dental-professional prophylaxis brush, single-useA non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
100
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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30732224001136Self-Sealing Sterilization BagOCS2022-05-03
50732224005206Premium Non-Woven SpongesENCNW4KENCNW4K2025-10-23
50732224001086Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2025-10-23
10732224001088Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2022-08-25
10732224005208Premium Non-Woven SpongesENCNW4KENCNW4K2023-07-17
50732224000140Sani Vac Evacuation System CleanerJVACSAMPLESJVACSAMPLES2022-08-19
10732224110568Duo-Check Self-Sealing Sterilization PouchesSCM2025-07-24
10732224000050Crosstex InternationalSCMSCM2016-11-11
10732224109241Duo-Check Self-Sealing Sterilization PouchesSCB1XSCB1X2016-11-11
10732224109272Duo-Check Self-Sealing Sterilization PouchesSCLSCL2016-11-11
10732224109289Duo-Check Self-Sealing Sterilization PouchesSCL1015SCL10152016-11-11
10732224109296Sure-Check Self Sealing Sterilization PouchesSCL10152SCL101522016-11-11
10732224109319Sure-Check Self Sealing Sterilization PouchesSCL10172SCL101722017-02-11
10732224109326Duo-Check Self-Sealing Sterilization PouchesSCL1215SCL12152016-11-11
10732224109333Sure-Check Self Sealing Sterilization PouchesSCL12152SCL121522016-11-11
10732224109357Duo-Check Self-Sealing Sterilization PouchesSCL1218SCL12182016-11-11
10732224109364Sure-Check Self Sealing Sterilization PouchesSCL12182SCL121822016-11-11
10732224109388Sure-Check Self Sealing Sterilization PouchesSCL2SCL22016-11-11
10732224109395Duo-Check Self-Sealing Sterilization PouchesSCL322SCL3222017-02-11
10732224109401Sure-Check Self Sealing Sterilization PouchesSCL3222SCL32222017-02-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04548213057375TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
03663394482325HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-08-20
D950116461PastelLARES RESEARCHEFA2025-05-02
03663394170871IMPULSIONETABLISSEMENTS ANTHOGYREFA2025-02-13
00304040189641MaximaHENRY SCHEIN, INC.EFA2025-01-14
EKAV101402800MASTERmatic LUX M45 LKaVo Dental GmbHEFA2024-02-01
03663394170796AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-28
03663394169929AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-27
03663394169936AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-27
04548213745043Midwest 45 FBE NFOJ.MORITA MFG.CORP.EFA2023-08-18
04548213745241Midwest 45 K-Style NFOJ.MORITA MFG.CORP.EFA2023-08-18
04548213008476N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008483N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008506N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008513TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008537TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008544TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008551TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008568TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008575TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
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