What is FDA product code NYE?

Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. 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 › ProstheticFixture Mount Kit

3DDX Tapered Drill Kit

Name: 3DDX Tapered Drill Kit
Brand: 3DDX Tapered Drill Kit

A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not…

Registry build 21.09.26

A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1).

Chinese manufacturers registered for FDA product code NYE
Manufacturer	City	Province	Registered as	Device types
BIO Concept Co., Ltd.	Changzhou	Jiangsu	Manufacturer	5
Zhuhai Meierjing Medical Instrument Co., Ltd.	Zhuhai	Guangdong	Manufacturer	2

Record

Regulatory record for 3DDX Tapered Drill Kit
Listed by	3D Diagnostix Inc, United States
FDA product code	NYE
Device type	Fixture Mount Kit
Device class	Class 1
Regulation	21 CFR 872.3980
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2025-09-10

Specifications

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

Catalogue Numbers

Catalogue numbers for 3DDX Tapered Drill Kit
Catalogue number	Size	Status
Dental/maxillofacial surgical procedure kit, non-medicated, reusable / Tapered		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Intra-Lock	Intra-Lock International	13
Taper KIT	Osstem Implant Co., Ltd.	8
122 Taper Full KIT	Osstem Implant Co., Ltd.	7
122 Taper KIT	Osstem Implant Co., Ltd.	6
485 KIT	Osstem Implant Co., Ltd.	6
Bone Compaction KIT	Osstem Implant Co., Ltd.	6
Taper Ultra KIT	Osstem Implant Co., Ltd.	5
123 Straight Full KIT	Osstem Implant Co., Ltd.	4
Esset KIT	Osstem Implant Co., Ltd.	4
123 Straight KIT	Osstem Implant Co., Ltd.	3
Prosthetic KIT	Osstem Implant Co., Ltd.	3
OneGuide KIT	Osstem Implant Co., Ltd.	3

Showing 12 of 79. All products under Fixture Mount Kit

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.