FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERMADYNE ADHESIVE
K Number: K875228
·
Decision Mar 9, 1988
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
29
Applicant Total
59
Review Days
78
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
- PERMADYNE ADHESIVE
- K Number
- K875228
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3670
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe GmbH (Us)
- Date Received
- December 22, 1987
- Decision Date
- March 9, 1988
- Product Code
- EBH
- 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 |
|---|---|---|---|
| EBH | Material, Impression Tray, Resin | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBH), ordered by most recent decision date.
PERMAGEN UNIVERSAL BONDING RESIN
FDA 510(k)
FDA Class 1
·Dental
PALATRAY LC MINT
FDA 510(k)
FDA Class 1
·Dental
LC TRAY MATERIAL
FDA 510(k)
FDA Class 1
·Dental
PALADISC LC
FDA 510(k)
FDA Class 1
·Dental
POLYESTER RESIN HAND MOLDED TRAY
FDA 510(k)
FDA Class 1
·Dental
PALAVIT L
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Espe GmbH (Us)
| K Number | Device Name | ||
|---|---|---|---|
| K925027 | PHOTAC-FIL APLICAP | Jun 18, 1993 | Substantially Equivalent |
| K915005 | PHOTAC-BOND APLICAP, MODIFICATION | Jan 14, 1992 | Substantially Equivalent |
| K913966 | SONO(R) -CEM | Jan 14, 1992 | Substantially Equivalent |
| K913857 | ROCATEC(R) -PLUS | Dec 16, 1991 | Substantially Equivalent |
| K913965 | ESPE(R) -SIL | Dec 4, 1991 | Substantially Equivalent |
| K905604 | VISIO-GEM ART-SYSTEM | Mar 29, 1991 | Substantially Equivalent |
| K904096 | PHOTAC-BOND | Nov 19, 1990 | Substantially Equivalent |
| K904097 | PHOTAC-BOND APLICAP | Nov 9, 1990 | Substantially Equivalent |
| K904289 | PERTAC UNIVERSAL BOND | Nov 1, 1990 | Substantially Equivalent |
| K900510 | PERTAC-HYBRID | Aug 9, 1990 | Substantially Equivalent |