FDA.report

CIRCULAR KNIFE CMU 5.1mm

Primary DI
D928107227510
Brand
CIRCULAR KNIFE CMU 5.1mm
Company
W.H. Holden, Inc.
Model
10-7227-51
Published
2023-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMEPUNCH, BIOPSY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D928107227510PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental soft-tissue coring punch, reusableA dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
183854322
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
D9281051992HF0SINUS INSTRUMENT #2 HF D/E10-5199-2HF2026-02-19
D928400527H0POWERTOME S/E HF HANDLE40-0527H2026-01-27
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE10-6122-R452026-01-15
D9281059552HF570CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG10-5955-2HF572026-01-14
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLE40-0101CH2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLE40-0102CH2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE40-0102R2026-01-14
D9284001040D928400104040-01042026-01-14
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLC10-0600-962DLC2026-01-06
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM10-0930-18-52026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MM10-0930-23-62026-01-06
D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLC10-5106HDHF-DLC2026-01-06
D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLC10-5109JHF59DLC2026-01-06
D928105402HF0PERIOSTEAL ELEVATOR LANGER, MIRROR FINISH, HF D/E10-5402HF2026-01-06
D928105410CH0PERIOSTEAL ELEVATOR HOWARD #9H CH D/E10-5410CH2026-01-06
D928105488CHDLC0PERIOSTEAL ELEVATOR WOODSON SPEAR AND PERIO KNIFE, CH D/E DLC10-5488CHDLC2026-01-06
D928105489RK0PERIOSTEAL ELEVATOR, MODIFIED BUSER, ROUND KNURLED HANDLE, D/E10-5489RK2026-01-06
D928105490R0CURETTE, MODIFIED MOLT 2CH / 4HD, ROUND HANDLE, D/E10-5490R2026-01-06
D9281055350"OH" ZYGOMA RETRACTOR10-55352026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
40649111231422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233150Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233501Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233785Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111234102Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
00841336113527Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336128712Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336113534Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2024-12-11
80080196029135MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
80080196029210MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
80080196030315MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
80080196030636MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
80080196025748MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
80080196028992MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
80080196029098MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
80080196024857MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
80080196024949MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
80080196028916MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
10193489141122MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141139MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141146MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141153MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141160MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141177MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141184MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141207MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141214MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141238MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
08800075612755OSUNG MNDOSUNG MND Co., Ltd.EME2024-03-04
08800075612762OSUNG MNDOSUNG MND Co., Ltd.EME2024-03-04