What is FDA product code NYD?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Dental › ProstheticEndodontic Kit

Dental Engineering Lab-TFRK

Name: Dental Engineering Lab-TFRK
Brand: Dental Engineering Lab-TFRK

The File Retrieval Kit w/ Satelec Ultrasonic Tips and Loop+

Registry build 21.09.26

2manufacturers in China registered for this device type

4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangxi (1), Hunan (1).

Chinese manufacturers registered for FDA product code NYD
Manufacturer	City	Province	Registered as	Device types
Guilin Woodpecker Medical Instrument Co., Ltd.	Guilin	Guangxi	Manufacturer	25
Denjoy Dental Co., Ltd.	Changsha	Hunan	Contract manufacturer	17

Record

Regulatory record for Dental Engineering Lab-TFRK
Listed by	Dental Engineering Laboratories, LLC, United States
FDA product code	NYD
Device type	Endodontic Kit
Device class	Class 2
Regulation	21 CFR 872.3820
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2022-08-22
Record revised	2019-08-30 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Dental Engineering Lab-TFRK
Catalogue number	Size	Status
TFRK-EMS+		In distribution
TFRK-SET+		In distribution
TFRK-SET		In distribution
TFRK-EMS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stradis	Stradis Healthcare	1
Stradis Healthcare	Stradis Healthcare	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.