FDA.reportPublic FDA data

Young

Primary DI
00302732814123
Brand
Young
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
281412
Catalog number
281412
Device description
Young Mandrel Right Angle - Latch Type 14mm, Nickel Plated Brass, Screw type
Published
2022-10-16
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
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790722000PROPHYLAXIS ANGLEYoung Dental Manufacturing Co. 1, LLC1979-06-15EGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302732814120PackageGS112In Commercial Distribution
00302732814123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030273281412010302732814120
00302732814123003027328141233027328141230302732814123

GMDN Terms#

Term, Definition table
TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. 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
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
00302730001723Young2962672962672026-05-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29