← Product Code [NUN](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN) · K103699

# EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (K103699)

_Exactech, Inc. · NUN · Aug 12, 2011 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K103699

## Device Facts

- **Applicant:** Exactech, Inc.
- **Product Code:** [NUN](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN.md)
- **Decision Date:** Aug 12, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3930
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

## Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K103699](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NUN/K103699)

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