FDA.reportPublic FDA data

Select Orange Vanilla Medium Prophy Paste (200)

Primary DI
00815878021893
Brand
Select Orange Vanilla Medium Prophy Paste (200)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72721451
Published
2019-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00815878021893PackageGS1200In Commercial Distribution
00815878021886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878021893008158780218938158780218930815878021893
00815878021886008158780218868158780218860815878021886

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
800-562-8176customerservice@burkhartdental.com

Regulatory Flags#

DUNS number
027532357
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
00815878027628Burkhart Dental Supply727220272024-05-07
00815878027642Burkhart Dental Supply727220292024-05-07
00810052614458Burkhart Dental Supply727218522024-01-26
00810052614557Burkhart Dental Supply727218502024-01-26
00810052614564Burkhart Dental Supply727218482024-01-26
00810052615042Burkhart Dental Supply727218542024-01-26
00810052615899Burkhart Dental Supply727218552024-01-26
00810052616780Burkhart Dental Supply727218562024-01-26
00810052617770Burkhart Dental Supply727219622024-01-26
00810052618883Burkhart Dental Supply727219632024-01-26
00810052619873Burkhart Dental Supply727218572024-01-26
00810052619996Burkhart Dental Supply727219642024-01-26
00810052610306Burkhart Dental Supply727218402024-01-15
00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15

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
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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