# Dental Abutment Design Software For Dental Laboratory
> **Product code: PNP** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3630
## Classification
- **FDA Product Code:** PNP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.3630
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 8
- **Registered establishments:** 55
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PNP)
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