Guard, Disk
The Disk Guard is a dental safety device fitted over a rotating abrasive or cutting disk used in a dental handpiece to protect the patient's soft tissues and the clinician's fingers from accidental contact with the spinning disk during intraoral use. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EEJ and the applicable regulation is 21 CFR 872.6010, under the Dental medical specialty.
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Basic Information
- Product Code
- EEJ
- Device Class
- FDA class 1
- Regulation Number
- 872.6010
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854467 | S.T.P.B SOFT TISSUES PROTECTIVES BLADES | Mar 12, 1986 | Substantially Equivalent | Nortex USA, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.