FDA.reportPublic FDA data

Twist Prophy Angles Disposable Cup

Primary DI
10732224003341
Brand
Twist Prophy Angles Disposable Cup
Company
CROSSTEX INTERNATIONAL, INC.
Model
TPAFC
Device description
Prophy Angles Disposable Cup Firm Cup, White
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
50732224003349PackageGS112In Commercial Distribution
10732224003341PrimaryGS10
00732224003344Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400334950732224003349
1073222400334110732224003341
00732224003344007322240033447322240033440732224003344

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. 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
Primary DIBrandModelCatalogPublished
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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03663394482325HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-08-20
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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
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