FDA.reportPublic FDA data

Soft Tissue Harvester

Primary DI
08806388238835
Brand
Soft Tissue Harvester
Company
Megagen Implant Co. Ltd
Model
TCMSTH5010
Catalog number
TCMSTH5010
Device description
Common L=5/ H=1
Published
2015-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
08806388238835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388238835088063882388358806388238835

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.

Regulatory Flags#

DUNS number
687388178
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388277483Healing AbutmentAOHS50652NAOHS50652NT2023-06-08
08806388286973Healing AbutmentAOHM60907AOHM60907T2023-06-08
08806388286980Healing AbutmentAOHM70802AOHM70802T2023-06-08
08806388286997Healing AbutmentAOHM70803AOHM70803T2023-06-08
08806388287000Healing AbutmentAOHM70804AOHM70804T2023-06-08
08806388287017Healing AbutmentAOHM70805AOHM70805T2023-06-08
08806388287024Healing AbutmentAOHM70807AOHM70807T2023-06-08
08806388287031Healing AbutmentAOHM70902AOHM70902T2023-06-08
08806388287048Healing AbutmentAOHM70903AOHM70903T2023-06-08
08806388287055Healing AbutmentAOHM70904AOHM70904T2023-06-08
08806388287062Healing AbutmentAOHM70905AOHM70905T2023-06-08
08806388287079Healing AbutmentAOHM70907AOHM70907T2023-06-08
08806388287086Healing AbutmentAOHM70102AOHM70102T2023-06-08
08806388287093Healing AbutmentAOHM70103AOHM70103T2023-06-08
0880638828710908806388287109AOHM70104AOHM70104T2023-06-08
08806388287116Healing AbutmentAOHM70105AOHM70105T2023-06-08
08806388287123Healing AbutmentAOHM70107AOHM70107T2023-06-08
08806388287130Healing AbutmentAOHM80902AOHM80902T2023-06-08
08806388287147Healing AbutmentAOHM80903AOHM80903T2023-06-08
08806388287154Healing AbutmentAOHM80904AOHM80904T2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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