Eactech Optecure Dental and Optecure Dental + CCC
FDA 510(k) K103699 · Exactech, Inc.
510(k) numberK103699
Submission
- Device name
- Eactech Optecure Dental and Optecure Dental + CCC
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- December 20, 2010
- Decision date
- August 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUN – Bone Grafting Material, Human Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE…
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Questions and answers
When was Eactech Optecure Dental and Optecure Dental + CCC cleared by the FDA?
Eactech Optecure Dental and Optecure Dental + CCC (K103699) received a 510(k) decision of Substantially Equivalent on August 12, 2011, 235 days after the submission was received.
What is the product code of K103699?
The FDA product code is NUN – Bone Grafting Material, Human Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.