FDA.reportPublic FDA data

Henry Schein Acclean

Primary DI
00304040184875
Brand
Henry Schein Acclean
Company
HENRY SCHEIN, INC.
Model
5703774
Catalog number
5703774
Device description
Acclean Scalers
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELAINSTRUMENT, HAND, CALCULUS REMOVAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040184875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040184875003040401848753040401848750304040184875

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810132809446House Brand DentistryFrontier Dental Supply IncELA2026-02-10
00810132809439House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809453House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809460House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00047701001813DentekDenTek Oral Care, Inc.ELA2024-06-19
ESAM1820001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1825001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1826001STOMA®Storz am Mark GmbHELA2020-08-27
00840018624139NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625068NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625235NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625242NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625259NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625266NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625273NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018616851NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616868NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616875NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616882NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616899NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616905NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616912NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616929NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616936NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616943NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616950NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616967NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616974NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616981NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616998NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12