FDA.reportPublic FDA data

Twist Prophy Angles Disposable Flat Brush

Primary DI
50732224003363
Brand
Twist Prophy Angles Disposable Flat Brush
Company
CROSSTEX INTERNATIONAL, INC.
Model
TPAFB
Device description
Twist™ Disposable Prophy Angles, Flat Brush
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
50732224003363PackageGS14In Commercial Distribution
10732224003365PrimaryGS10
00732224003368Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400336350732224003363
1073222400336510732224003365
00732224003368007322240033687322240033680732224003368

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057728685
Device count
100
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04548213060160STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060177STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213057320TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057337TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057344TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057368TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
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
04548213008582TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008599TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12