FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUD MAXILLOFACIAL IMPLANT SYSTEM
K Number: K913688
·
Decision May 5, 1992
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
3
Review Days
260
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
- BUD MAXILLOFACIAL IMPLANT SYSTEM
- K Number
- K913688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bud Industries, Inc.
- Date Received
- August 19, 1991
- Decision Date
- May 5, 1992
- Product Code
- JEY
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEY), ordered by most recent decision date.
Leforte MMF System
FDA 510(k)
FDA Class 2
·Dental
Southern Craniomaxillofacial (CMF) System
FDA 510(k)
FDA Class 2
·Dental
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
FDA 510(k)
FDA Class 2
·Dental
KLS Martin Oral-Max Implants MR Conditional (bundled)
FDA 510(k)
FDA Class 2
·Dental
MRI Universal
FDA 510(k)
FDA Class 2
·Dental
tmCMF Solution
FDA 510(k)
FDA Class 2
·Dental