Grafton DBM
FDA 510(k) K051188 · Osteotech, Inc.
510(k) numberK051188
Submission
- Device name
- Grafton DBM
- Applicant
- Osteotech, Inc.
Eatontown, NJ, US - Received
- May 10, 2005
- Decision date
- January 3, 2006
- 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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| K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone…MQV · Traditional | 10/16/2008SE |
| K081227 | Plexur MMQV · Traditional | 07/22/2008SE |
| K080511 | Plexur-PMQV · Traditional | 04/21/2008SE |
| K073405 | Plexur MMQV · Traditional | 03/03/2008SE |
| K061982 | Plexur PMBP · Traditional | 02/07/2007SE |
| K051781 | Graftcage TLXMQP · Traditional | 12/16/2005SE |
| K051195 | Grafton DBMMBP · Traditional | 12/16/2005SE |
| K043209 | Viagraf DBM PasteMBP · Traditional | 12/05/2005SE |
| K053080 | Graftcage AcxMQP · Traditional | 12/01/2005SE |
| K042707 | Grafton Plus DBM PasteNUN · Traditional | 11/30/2005SE |
Questions and answers
When was Grafton DBM cleared by the FDA?
Grafton DBM (K051188) received a 510(k) decision of Substantially Equivalent on January 3, 2006, 238 days after the submission was received.
What is the product code of K051188?
The FDA product code is NUN – Bone Grafting Material, Human Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.