FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K Number: K791326
·
Decision Oct 17, 1979
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
191
Review Days
97
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
- K Number
- K791326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- July 12, 1979
- Decision Date
- October 17, 1979
- Product Code
- DZI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZI), ordered by most recent decision date.
Implantmed Plus II & Piezomed Plus II Module
FDA 510(k)
FDA Class 2
·Dental
VarioSurg 4
FDA 510(k)
FDA Class 2
·Dental
MT-Bone
FDA 510(k)
FDA Class 2
·Dental
Surgical Drive System (Model: ES70, ES90, E8)
FDA 510(k)
FDA Class 2
·Dental
Guided Surgery Kit
FDA 510(k)
FDA Class 2
·Dental
TRAUS SUS20
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Sherwood Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | Nov 25, 1998 | Substantially Equivalent |
| K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | Dec 23, 1996 | Substantially Equivalent |
| K962880 | SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM | Dec 9, 1996 | Unknown |
| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Aug 5, 1996 | Substantially Equivalent |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | May 13, 1996 | Substantially Equivalent |
| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |