What is FDA product code PNP?

The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.

Dental › ProstheticDental Abutment Design Software For Dental Laboratory

Fastdesign.io

Name: fastdesign.io
Brand: fastdesign.io

fastdesign.io™ (including two-piece hybrid abutments and dental restorations design)

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PNP
Manufacturer	City	Province	Registered as	Device types
Exceldent Dental Technology Development Co., Ltd.	Zhuhai	Guangdong	Contract manufacturer	12
Shimmer Computerized Dental Technology Co., Ltd.	Zhuhai	Guangdong	Contract manufacturer	10

Record

Regulatory record for fastdesign.io
Listed by	Prismatik Dentalcraft, Inc., United States
FDA product code	PNP
Device type	Dental Abutment Design Software For Dental Laboratory
Device class	Class 2
Regulation	21 CFR 872.3630
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2026-07-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for fastdesign.io
Catalogue number	Size	Status
70-1181-MIL0467		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
IPD	Implant Protesis Dental 2004 SL	317
BruxZir®	Prismatik Dentalcraft, Inc.	62
Preat	Preat Corporation	46
MEDENTiKA	Medentika GmbH	36
Cerec Tessera	Degudent Gmbh	15
BioHorizons	Biohorizons Implant Systems Inc.	10
Nobel Biocare N1™	Nobel Biocare AB	10
CAD/CAM Software	Sirona Dental Systems Gmbh	9
Dental Abutment Design Software For Dental Laboratory	Nobel Biocare AB	7
Cerec	Degudent Gmbh	6
Preat Implant Prosthetics	Preat Corporation	4
DTX Studio™ Lab	Nobel Biocare AB	4

Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231529	2024-03-14

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.