FDA.report

Metal Scaler

Primary DI
08809917070623
Brand
Metal Scaler
Company
Osstem Implant Co., Ltd.
Model
OICSME
Published
2023-08-07
Public version status
New
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
EMNScaler, Periodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809917070623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809917070623088099170706238809917070623

GMDN Terms

TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
689051793
Device count
1
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
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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