FDA.report

Select Cherry Medium Prophy Paste (200)

Primary DI
00815878021787
Brand
Select Cherry Medium Prophy Paste (200)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72721415
Published
2019-04-12
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

Related Records

Contact Domains

Product Codes

CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815878021787PackageGS1200In Commercial Distribution
00815878021770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878021787008158780217878158780217870815878021787
00815878021770008158780217708158780217700815878021770

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
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00815878027642Burkhart Dental Supply727220292024-05-07
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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

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