Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6300](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6300) → PYQ — Rfid Chip For Dental Appliance

# PYQ · Rfid Chip For Dental Appliance

_General Hospital · 21 CFR 880.6300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PYQ

## Overview

- **Product Code:** PYQ
- **Device Name:** Rfid Chip For Dental Appliance
- **Regulation:** [21 CFR 880.6300](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6300)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.

## Classification Rationale

Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K170423](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PYQ/K170423.md) | DentureID Microchip | Cmp Industries, LLC | Oct 25, 2017 | SESE |

## Top Applicants

- Cmp Industries, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PYQ](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/PYQ)

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