Last synced on 23 September 2022 at 11:05 pm

Block, Bite

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5070
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.5070 Bite block

§ 882.5070 Bite block.

(a) Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.

(b) Classification. Class II (performance standards).

Block, Bite

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5070
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.5070 Bite block

§ 882.5070 Bite block.

(a) Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.

(b) Classification. Class II (performance standards).