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

Instrapac

Name: Instrapac
Brand: Instrapac

Instrapac Dental Exam Pack Plus with CPITN (WHO) Probe X40

Registry build 21.09.26

1manufacturer

13catalogue numbers in this listing

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 Instrapac
Listed by	Robinson Healthcare Limited, United Kingdom
FDA product code	NYC
Device type	Dental Prophylaxis Kit
Device class	Class 1
Regulation	21 CFR 872.4565
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2023-08-08
Record revised	2026-02-12 (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
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: keep dry and keep out of direct sunlight
Packaging	Box of 40
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Instrapac
Catalogue number	Size	Status
7015		In distribution
7141		In distribution
8459		In distribution
8140		In distribution
8878		In distribution
8460		In distribution
7812		In distribution
7123		In distribution
8166		In distribution
8884		In distribution
8167		In distribution
7814		In distribution
8458		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aligner Treatment Starter Kitz	Orthonu, LLC	1
Root Canal Instruments Kit	Denjoy Dental Co., Ltd.	1
SureSmile®	Dentsply Sirona Orthodontics Inc.	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.