INTRA-ORAL THERMOPLASTIC SHIELD

• K Number: K962622
• Device Name: INTRA-ORAL THERMOPLASTIC SHIELD
• Manufacturer: MEDTEC, INC.
• Date Cleared: 1996-10-01 ( 88 days)
• Product Code: KPY
• Regulation Number: 892.6500

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 892.6500 Personnel protective shield.

(a)
Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Summary

N/A