FDA.reportPublic FDA data

Defend

Primary DI
10843471123604
Brand
Defend
Company
Young Innovations, Inc.
Model
PP-1000
Catalog number
PP-1000
Device description
Prophylaxis Paste with 1.23% Fluoride Ion Reduced Splatter - COARSE ASSORTED
Published
2022-10-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843471123604PackageGS1200In Commercial Distribution
20843471123601PackageGS112In Commercial Distribution
00843471123607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347112360410843471123604
2084347112360120843471123601
00843471123607008434711236078434711236070843471123607

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 275-0020customerservice@defend.com

Regulatory Flags#

DUNS number
004193103
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
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
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810184450009RodinPac-Dent, Inc.EJR2026-03-23
00810184450016RodinPac-Dent, Inc.EJR2026-03-23
00810184450023RodinPac-Dent, Inc.EJR2026-03-23
E241BW9100Cavex Prophy Paste RegularCavex Holland B.V.EJR2026-03-11
E241BW9110Cavex Prophy Paste FineCavex Holland B.V.EJR2026-03-11
00883205042835OpalustreULTRADENT PRODUCTS, INC.EJR2026-03-10
10190707191174Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310231029993ProphyCare HApDirecta ABEJR2025-09-01
00348783012989Enamel Pro® Prophy PastePREMIER DENTAL PRODUCTS COMPANYEJR2025-07-16
00304040192771Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
06971560453466REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453473REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453480REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453497REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453503REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
D0337884100Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D0337884110Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D950116471PastelLARES RESEARCHEJR2025-05-02
D950116481PastelLARES RESEARCHEJR2025-05-02
00359883003081Contours™ Coarse Anatomy Trimmers Shape 05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003098Contours™ Coarse Anatomy Trimmers Shape 06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003104Contours™ Coarse Anatomy Trimmers Shape 08DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003111Contours™ Course Anatomy Trimers Starter KitDEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003500D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003517D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003524D-Fine™ Diamond Polishers for Hybrid Composites Diamond Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003609D-Fine Double Diamond™ Primary Polisher Refill #04DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003616D-Fine Double Diamond™ Primary Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003623D-Fine Double Diamond™ Primary Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003630D-Fine Double Diamond™ Primary Polisher Refill #08DEN-MAT HOLDINGS, LLCEJR2025-03-12