← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K241063

# s-Clean ScanHealing Abutment (K241063)

_Dentis Co., Ltd. · NHA · Jul 25, 2024 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K241063

## Device Facts

- **Applicant:** Dentis Co., Ltd.
- **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md)
- **Decision Date:** Jul 25, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3630
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

## Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K241063](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K241063)

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