Bar, Preformed
The Preformed Bar is a prefabricated metal component used in the construction of removable partial dentures and orthodontic appliances, providing structural support and a standardized shape that dental laboratory technicians adapt to individual patient needs. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHO, regulated under 21 CFR 872.3165 in the Dental (DE) specialty.
Basic Information
- Product Code
- EHO
- Device Class
- FDA class 1
- Regulation Number
- 872.3165
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934468 | SLIP-ON FIXATION SPLINT (SFS) | Aug 05, 1994 | Substantially Equivalent | GATEWOOD SPLINTS |
| K881133 | 70-X/RVG (RADIOVISIOGRAPHY) | Jul 20, 1989 | Substantially Equivalent | TROPHY RADIOLOGIE |
| K883388 | DENTREK BRIDGE BARS | Oct 06, 1988 | Substantially Equivalent | DALE T. DUPUIS |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.