| Device |
dental waterline treatment cartridge |
| Regulation Description |
Dental operative unit and accessories. |
| Definition |
Intended to reduce microbial bioburden in dental unit water lines |
| Physical State |
Inline cartridge for water line to the dental operative unit |
| Technical Method |
Resin filtration with or without chemical agent to purify or treat incoming water for dental operative unit. These devices are subject to EPA registration under FIFRA https://www.epa.gov/pesticide-registration/pr-notice-94-4-mou-regulation-liquid-chemical-germicides-intended-use |
| Target Area |
Intraoral exposure to treated water |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | QYJ |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
872.6640
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
