FDA.reportPublic FDA data

Young

Primary DI
00302730001723
Brand
Young
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
296267
Catalog number
296267
Device description
Young Hygiene Handpiece - Purple, 3 Purple Nosecones
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHandpiece, air-powered, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974671000ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTORAthena Technology, Inc.1998-03-11EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302730001720PackageGS11In Commercial Distribution
20302730001727PackageGS112In Commercial Distribution
00302730001723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030273000172010302730001720
2030273000172720302730001727
00302730001723003027300017233027300017230302730001723

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement system handpieceA holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 325-1881customerservice@younginnovations.com

Regulatory Flags#

DUNS number
006309355
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00302730001730Young2962652962652026-05-15
10302732957827Varnish Pen - Assorted2957822017-07-17
10302730701309Varnish America 0.25ml Box / 200 White Bubblegum07-01302017-08-31
10302732958350Varnish Pen - Mint2958352017-07-17
10302732958367Varnish Pen - Assorted2958362017-07-17
00302730002508Zooby2962012962012022-10-16
10302733701016Etching Gel 5mL/20 Tips3701012016-09-23
10302733701047Etching Gel 5 mL/40 Tips3701042016-09-23
00302730003383Young Dental2969972025-09-05
00302732322253Young Dental2322252322252025-02-17
00302732342251Young Dental2342252342252025-02-17
10302732958305Barrier Sleeve, Young Infinity Cordless Handpiece, 25ct2958302018-05-25
10302732958312Barrier Sleeve, Young Infinity Cordless Handpiece, 500ct2958312018-05-25
10302736702508Short Pen Sleeve6702502017-10-27
10302736703505Light Handle Sleeve6703502017-10-27
10302736704502Low Speed Handpiece Sleeve6704502017-10-27
00302730002348Young2958302958302022-10-16
00302730002355Young2958312958312022-10-16
00302730002362Denticator6700506700502022-10-16
00302730002379Denticator6702506702502022-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301280011WE-57 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301290011HE-43 T SD Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11