FDA.reportPublic FDA data

Young

Primary DI
10302731770014
Brand
Young
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
177001
Catalog number
177001
Device description
Young Original Rubber Dam Frame, Standard, 7 Tines,4 1/8 in. X 3 5/8 in. (10.4 cm x 9.2 cm)
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJEFRAME, RUBBER DAM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJEFrame, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302731770014PackageGS11In Commercial Distribution
00302731770017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030273177001410302731770014
00302731770017003027317700173027317700170302731770017

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam frameA flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
G149TBSB2100TBS BASICSACME ENTERPRISE.EJE2026-05-16
00813677023339PDT, Inc.PDT, INC.EJE2024-06-27
00813677024985PDT, Inc.PDT, INC.EJE2024-06-27
D2483553190Plast FrameHAGER WORLDWIDE, INC.EJE2024-04-16
08800075603463OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
08800075603470OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
07506338321761Nic Tone, MDC Dental MDC DENTALEJE2023-11-17
00014081053190Plast FrameHAGER WORLDWIDE, INC.EJE2023-03-27
07630392900409HysolateDent4You AGEJE2023-02-28
07630392900416HysolateDent4You AGEJE2023-02-28
07630392900423HysolateDent4You AGEJE2023-02-28
07630392900430HysolateDent4You AGEJE2023-02-28
07630392900447HysolateDent4You AGEJE2023-02-28
07506338300575Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300667Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300674Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300681Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300698Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300704Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300568Nic Tone, MDC DentalMDC DENTALEJE2022-12-08
07506338300599Nic Tone, MDC Dental MDC DENTALEJE2022-12-08
D24835531919Plast FrameHAGER WORLDWIDE, INC.EJE2022-12-05
07506338300582Nic Tone, MDC DentalMDC DENTALEJE2022-11-04
07506338300636Nic Tone, MDC Dental MDC DENTALEJE2022-11-03
00302731714011YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731770017YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731771014YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731776019YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731777016YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731714018YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16