FDA.report

Premier

Primary DI
D6911005336
Brand
Premier
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1005336
Device description
Implant Ultrasonic Insert 30K
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ELCScaler, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6911005336PrimaryHIBCC0

GMDN Terms

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).

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
014789663
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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