FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040165119
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702138
Catalog number
5702138
Device description
Acclean Easy Grip XL Triple Bend Slim #1000 25K
Published
2022-07-18
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

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
00304040165119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040165119003040401651193040401651190304040165119

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).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506238Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506245Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506252Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506276Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506283Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506290Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506306Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506313Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506320Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
07613353180089Instruments A P PSE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353180096Instruments PS PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353336837Instruments PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
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04589551388936VA170-SCNAKANISHI INC.ELC2026-02-13
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04560264577763VA2-LUX-HP TiNAKANISHI INC.ELC2026-02-13
04589551387168Tip Cover LNAKANISHI INC.ELC2026-01-21
04589551387151Tip Cover SNAKANISHI INC.ELC2026-01-21
04589551382828E TIP WRENCHNAKANISHI INC.ELC2026-01-21
04589551387144VariosNAKANISHI INC.ELC2026-01-21
04560264579958CLA-10NAKANISHI INC.ELC2026-01-21
045895513889743 Mode Select SwitchNAKANISHI INC.ELC2026-01-21