FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIVADENT FILPIN
K Number: K863831
·
Decision Oct 14, 1986
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
10
Applicant Total
17
Review Days
14
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
- VIVADENT FILPIN
- K Number
- K863831
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Vivadent (Usa), Inc.
- Date Received
- September 30, 1986
- Decision Date
- October 14, 1986
- Product Code
- EBL
- 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 |
|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBL), ordered by most recent decision date.
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
FDA 510(k)
FDA Class 1
·Dental
DENTAURUM JACKET CROWN & ROOT POSTS
FDA 510(k)
FDA Class 1
·Dental
ROOT CANAL POST
FDA 510(k)
FDA Class 1
·Dental
PROSTHETIC RESTORATION DEVICE
FDA 510(k)
FDA Class 1
·Dental
PLASTIC TOOTH REINFORCEMENT KIT
FDA 510(k)
FDA Class 1
·Dental
ELGILOY
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Vivadent (Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823409 | HELIOSIT-ORTHODONTIC | Jan 21, 1983 | Substantially Equivalent |
| K813015 | HELIOSEAL | Dec 2, 1981 | Substantially Equivalent |
| K802679 | SILANIT | Dec 17, 1980 | Substantially Equivalent |
| K802682 | CONTACT SEAL | Nov 24, 1980 | Substantially Equivalent |
| K802681 | HELIOBOND | Nov 24, 1980 | Substantially Equivalent |
| K802683 | HELIOSIT | Nov 24, 1980 | Substantially Equivalent |
| K802684 | HELIOMAT | Nov 24, 1980 | Substantially Equivalent |
| K802685 | REOLIT | Nov 12, 1980 | Substantially Equivalent |
| K802680 | ISOPAST-DS | Nov 12, 1980 | Substantially Equivalent |
| K801227 | SILICAP | Aug 12, 1980 | Substantially Equivalent |