FDA.reportPublic FDA data

Pro-Select Platinum®

Primary DI
D813S309601
Brand
Pro-Select Platinum®
Company
DEN-MAT HOLDINGS, LLC
Model
S30960
Catalog number
S30960
Device description
PSP TIPS – UNIV STRT 3PK
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964596000PROSELECT 3 PERIDONTAL THERAPY SYSTEMProfessional Dental Mfg., Inc.1997-04-22ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D813S309601PrimaryHIBCC0
D813S309600Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use this product in presence of inflammable anesthetics or gases
Special Storage Condition, Specify00Keep away from explosive substances and flammable materials
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Moist Heat or Steam Sterilization"", ""High-level Disinfectant""]"
Liquid Chemical;Moist Heat or Steam Sterilization;High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
3
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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