FDA.report

Young

Primary DI
20302731346124
Brand
Young
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
134612
Catalog number
134612
Device description
Young DPA Classic Petite Web, Latex Free, Soft, Short, Purple Cup, 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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10302731346127PackageGS11200In Commercial Distribution
20302731346124PackageGS11In Commercial Distribution
00302731346120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030273134612710302731346127
2030273134612420302731346124
00302731346120003027313461203027313461200302731346120

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius49 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800) 325-1881customerservice@younginnovations.com

Regulatory Flags

DUNS number
006309355
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00302730003383Young Dental2969972025-09-05
10302732969509Young Core2969502025-06-11
00302730003307Young Dental2969062025-03-07
20302732311022Young Dental2311022311022025-02-17
20302732322004Young Dental2322002322002025-02-17
10302732322106Young Dental2322102322102025-02-17
10302732322250Young Dental2322252322252025-02-17
10302732330040Young Dental2330042330042025-02-17
00302732331026Young Dental2331022331022025-02-17
20302732342002Young Dental2342002342002025-02-17
10302732342104Young Dental2342102342102025-02-17
10302732342258Young Dental2342252342252025-02-17
10302732957186Young Dental2957182957182025-02-17
00302730003314Young Core2969272969272025-01-06
00302730003321Young Core2969282969282025-01-06
00302730003338Young Core2969292969292025-01-06
00302730003345Young Core2969302969302025-01-06
00302730003352Young Core2969312969312025-01-06
00302730003369Young Core2969322969322025-01-06
00302730003376Young Select2969332969332025-01-06

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