FDA.reportPublic FDA data

Johnson-Promident

Primary DI
00862314000370
Brand
Johnson-Promident
Company
JOHNSON-PROMIDENT
Model
UI-P1030
Device description
ultrasonic scaling insert
Published
2017-09-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862314000370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862314000370008623140003708623140003700862314000370

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
965230188
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862314000301Clear BlueDigi 2.02017-08-24
00862314000318Johnson-PromidentUI-S10S302017-09-06
00862314000325Johnson-PromidentUI-T10302017-09-06
00862314000332Johnson-PromidentUI-FS100252017-09-06
00862314000349Johnson-PromidentUI-P10252017-09-06
00862314000356Johnson-PromidentUI-T1000302017-09-06
00862314000363Johnson-PromidentUI-T3302017-09-06
00862314000387Johnson-PromidentUI-T10252017-09-06
00862314000394Johnson-PromidentUI-FS100302017-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04560264501935VA750-SCNAKANISHI INC.ELC2026-10-01
04560264501942VA-SCNAKANISHI INC.ELC2026-10-01
04560264501980Water Filter Set (2m)NAKANISHI INC.ELC2026-10-01
04560264503649VA560LUX-SCNAKANISHI INC.ELC2026-10-01
04560264519022VA970-SCNAKANISHI INC.ELC2026-10-01
04560264519039VA970LUX-SCNAKANISHI INC.ELC2026-10-01
04560264522510VA570-SCNAKANISHI INC.ELC2026-10-01
04560264522527VA570LUX-SCNAKANISHI INC.ELC2026-10-01
04560264535213Water Filter Set (4m)NAKANISHI INC.ELC2026-10-01
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