FDA.reportPublic FDA data

Ultrasonic Scaler Insert

Primary DI
07290016281101
Brand
Ultrasonic Scaler Insert
Company
DELDENT LTD.
Model
DF3/25K
Catalog number
508600
Device description
Magnetostrictive dental scaler insert
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011179000DELDENT ULTRASONIC INSERTSDeldent , Ltd.2001-06-05ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016281101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016281101072900162811017290016281101

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600007124
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07290016281026MB coupling Midwest5051115051112022-11-22
07290016281033MB coupling Borden5051125051122022-11-22
07290016281040MB Quick coupling Kavo5051135051132022-11-22
07290016281057MB Quick coupling Sirona5051145051142022-11-22
07290016281064MB Quick coupling W&H5051175051172022-11-22
07290016281002Miniblaster Unit5050002016-09-24
07290016281019Miniblaster Nozzle Extension5051302016-09-24
07290016281705JETPOLISHER 2000BORDEN 1.15192002016-09-24
07290016281712JETPOLISHER 2000BORDEN 0.955192102016-09-24
07290016281729JETPOLISHER 2000MIDWEST 1.15193002016-09-24
07290016281736JETPOLISHER 2000MIDWEST 0.955193102016-09-24
07290016281743JETPOLISHER 2000 QD-S 1.15195002016-09-24
07290016281750JETPOLISHER 2000 QD-S 0.955195102016-09-24
07290016281767JETPOLISHER 2000QD - WH 1.15196002016-09-24
07290016281774JETPOLISHER 2000QD - WH 0.955196102016-09-24
07290016281781JETPOLISHER 2000QD - K 1.15199002016-09-24
07290016281798JETPOLISHER 2000QD - K 0.955199102016-09-24
07290016281804JP/JST/JS HANDPIECE BOOSTER5091112016-09-24
07290016281811JP/JST/JS HANDPIECE REGULAR5091202016-09-24
07290016281835JETSTREAM POWDER5000045000042022-03-16

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