FDA.report

SCOTT'S DISPOSABLE P/A 100/box FIRM CUP

Primary DI
D77824530010
Brand
SCOTT'S DISPOSABLE P/A 100/box FIRM CUP
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
245-3001
Catalog number
245-3001
Device description
SCOTT'S DISPOSABLE P/A 100/box FIRM CUP
Published
2021-02-27
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
EHKCUP, PROPHYLAXIS

Product Code Classifications

CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77824530011PrimaryHIBCC0
D77824530010Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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