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

Stradis Healthcare

Name: Stradis Healthcare
Brand: Stradis Healthcare

Custom Dental KIT, Perio, Oral Surgery

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

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 Stradis Healthcare
Listed by	Stradis Healthcare, United States
FDA product code	NYD
Device type	Endodontic Kit
Device class	Class 2
Regulation	21 CFR 872.3820
Premarket notification	Exempt
Record published	2022-03-21
Record revised	2023-02-07 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Distribution end date	2023-02-06

Catalogue Numbers

Catalogue numbers for Stradis Healthcare
Catalogue number	Size	Status
40473APP		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dental Engineering Lab-TFRK	Dental Engineering Laboratories, LLC	4
Stradis	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.