EHP · Clasp, Preformed
Dental · 21 CFR 872.3285 · Class 1
Overview
| Product Code | EHP |
|---|---|
| Device Name | Clasp, Preformed |
| Regulation | 21 CFR 872.3285 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022032 | ACETAL | Inovativ, LLC | Aug 29, 2002 | SESE |
| K983558 | ACETAL DENTAL/PREFORMED CLASP | Dentamax, Inc. | Jan 7, 1999 | SESE |
| K974622 | DENTAL D | Micro Dental Laboratories | Feb 10, 1998 | SESE |
| K955946 | ACETAL DENTAL/PREFORMED CLASP | Pressing DI Monticelli Rag. Stefano | Dec 11, 1995 | SESE |
| K954971 | ACETAL DENTAL/PREFORMED CLASP | B & H Technical Services , Ltd. | Dec 11, 1995 | SESE |
| K854765 | INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH | C&C Systems, Inc. | Jun 13, 1986 | SESE |
| K800575 | VACUDENT LUMIX 70 | Vacudent Sales Corp. | May 20, 1980 | SESE |
| K800574 | VACUDENT LUMIX 65 | Vacudent Sales Corp. | May 20, 1980 | SESE |
Top Applicants
- Vacudent Sales Corp. — 2 clearances
- Pressing DI Monticelli Rag. Stefano — 1 clearance
- Micro Dental Laboratories — 1 clearance
- Inovativ, LLC — 1 clearance
- Dentamax, Inc. — 1 clearance
