FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040046234
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1006840
Catalog number
1006840
Device description
Knife Orban DE 1/2
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMOKNIFE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040046234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040046234003040400462343040400462340304040046234

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00840018674011Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-11
00840018666009Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-09
00840018663367Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-04
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLEW.H. Holden, Inc.EMO2026-01-14
D9284001040D9284001040W.H. Holden, Inc.EMO2026-01-14
00841013121050Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121067Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121074Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121128Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121135Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121142Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121159Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
D9284005451HF0VESTIBULAR TUNNELING ELEVATOR #1 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005452HF0VESTIBULAR TUNNELING ELEVATOR #2 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005453HF0VESTIBULAR TUNNELING ELEVATOR #3 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005454HF0VESTIBULAR TUNNELING ELEVATOR #4 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005455HF0VESTIBULAR TUNNELING ELEVATOR #5 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005456HF0VESTIBULAR TUNNELING ELEVATOR #6 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
00840105223757ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223764ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223771ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223788ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223795ZOLL DENTALZoll-DentalEMO2025-08-06
D928400531HFDLC0PA TUNNELING INSTRUMENT #2 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400532HFDLC0PA TUNNELING INSTRUMENT #3 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400533HFDLC0PA TUNNELING INSTRUMENT #4 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400110HF0PERIO KNIFE, TOWNER 19/20, HFW.H. Holden, Inc.EMO2025-02-06