NEXT Fine Spearmint Prophy Paste Box 200

Primary DI
D0242202833
Brand
NEXT Fine Spearmint Prophy Paste Box 200
Company
Preventech
Model
220283
Catalog number
220283
Device description
NEXT Fine Spearmint Prophy Paste Box of 200 2.0g prophy cup units for dental prophylaxis procedures
Published
2023-06-13
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100539000PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, Inc.2010-06-17EJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D024220283PrimaryHIBCC0
D0242202833Unit of UseHIBCC0

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
7048492416customerservice@preventech.com

Regulatory Flags#

DUNS number
090735093
Device count
200
DM exempt
false
Premarket exempt
false
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

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