Description
This draft guidance document provides the FDA’s recommendations on device description, performance testing, and labeling to support premarket submissions for dental curing light devices. The recommendations are intended to promote consistency and facilitate efficient review of dental curing light submissions.
Scope & Applicability
Product Classes
1Devices that emit non-ionizing optical radiation intended to photopolymerize dental restorative resins.; Subject of the premarket notification guidance
Regulatory Context
Attributes
3Performance characteristic to be tested.; measure of the ability of dental curing lights to photopolymerize dental restorative resins
ability of dental curing lights to accumulate heat during normal operation
Performance characteristic to be tested.; measure of thickness of a dental restorative resin that can be cured
Identified Hazards
Hazards
2Excessive radiant power output can result in a thermal hazard
Warnings required in instructions for use
Related CFR Sections (6)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR872.6070§ 872.6070 Ultraviolet activator for polymerization.
(a) Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.Read full regulation →
- 21CFR878.4810§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a) Identification.Read full regulation →
- 21CFR872.6475§ 872.6475 Heat source for bleaching teeth.
(a) Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
Related Warning Letters (10)
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-08-26
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Uscom Kft
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Visgeneer, Inc
- 2025-07-29
CGMP/QSR/Medical Devices/Adulterated
Onkos Surgical, Inc.
- 2025-04-01
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Next Science LLC
- 2025-03-25
CGMP/QSR/Medical Devices/Adulterated
Dexcom, Inc.
- 2025-01-14
CGMP/QSR/Medical Devices/Adulterated
Randox Laboratories Limited
- 2025-01-14
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Xoran Technologies, LLC
- 2024-11-12
CGMP/QSR/Medical Devices/Adulterated
Owens & Minor, Inc. dba American Contract Systems, Inc.
- 2024-11-08
CGMP/QSR/Medical Devices/Adulterated
Micro-X Ltd.
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)