FDA.reportPublic FDA data

Safco CleanCare Pro Prophy Paste

Primary DI
00810063753818
Brand
Safco CleanCare Pro Prophy Paste
Company
SAFCO DENTAL SUPPLY CO.
Model
1023546
Catalog number
1023546
Device description
Safco CleanCare Pro prophy paste, coarse mint, 200/box
Published
2022-11-29
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

Product Codes#

Code, Name table
CodeName
CJRAcid phosphatase, thymol blue monophosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJRAcid Phosphatase, Thymol Blue MonophosphateClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810063753815PrimaryGS10
00810063753818Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006375381510810063753815
00810063753818008100637538188100637538180810063753818

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

Regulatory Flags#

DUNS number
020417380
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
D72310203523Prep&Etch™102-0352102-03522016-08-17
D72310203603Prep&Etch™102-0360102-03602016-08-17
D72310202123Safco TruCheck102021210202122022-06-17
D72310202133Safco TruCheck102021310202132023-07-31
D72310202153Safco TruCheck102021510202152022-06-17
D72310202173Safco TruCheck102021710202172022-06-17
D72310202183Safco TruCheck102021810202182023-07-31
D72310202193Safco TruCheck102021910202192022-06-17
D72310202213Safco TruCheck102022110202212022-06-17
D72310224053Safco Pure102240510224052022-03-30
10810063756243KIDS BUDDY Toothbrush8250071TK32025-03-19
10810063756250Power Curve Toothbrush82500830022025-03-19
10810063756267Esprit Ultra Fine Toothbrush82500872082025-03-19
10810063756274Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
10810063756281Power Curve Toothbrush8250093002-I2025-03-19
10810063756403Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
10810063756434KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
10810063756588Jr Series Comfort Grip Toothbrush82500892402025-03-19
10810063756595Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810063753815Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29
10810063753822Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29
10810063753839Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29
10810063753846Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29
00810063753825Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29
00810063753832Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29
00810063753849Safco CleanCare Pro Prophy PasteSAFCO DENTAL SUPPLY CO.CJR2022-11-29