What is FDA product code NYC?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.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 › SurgicalDental Prophylaxis Kit

SureSmile®

Name: SureSmile®
Brand: SureSmile®

SureSmile® Aligner Patient Kit (Global)

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code NYC
Manufacturer	City	Province	Registered as	Device types
Denjoy Dental Co., Ltd.	Changsha	Hunan	Contract manufacturer	17

Record

Regulatory record for SureSmile®
Listed by	Dentsply Sirona Orthodontics Inc., United States
FDA product code	NYC
Device type	Dental Prophylaxis Kit
Device class	Class 1
Regulation	21 CFR 872.4565
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2021-12-16
Record revised	2023-10-30 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for SureSmile®
Catalogue number	Size	Status
ORX00005		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Instrapac	Robinson Healthcare Limited	13
Aligner Treatment Starter Kitz	Orthonu, LLC	1
Root Canal Instruments Kit	Denjoy Dental Co., Ltd.	1
Braces Treatment Starter Kitz	Orthonu, LLC	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.