(195 days)
Alpha-bsm Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Alpha-bsm Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects: alveolar ridge augmentation (osteotomy. apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects, These defects include, but are not limited to, periodontal/infrabony alveolar defects: (osteotomy. apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous. intraoral and maxillofacial defects. These defects include, but are not limited to. periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Alpha-bsm Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a silicone bulb mixing system. The resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Alpha-bsm Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Beta-bsm Injectable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.
The provided text describes several bone substitute materials (Alpha-bsm, Beta-bsm, Gamma-bsm, EquivaBone) and their intended uses. However, it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of a quantifiable performance metric (e.g., accuracy, sensitivity, specificity).
Therefore, I cannot populate most of the requested fields. The document primarily focuses on:
- Device Description: What the device is composed of and how it works.
- Intended Use: The medical conditions and anatomical locations for which the device is indicated.
- Predicate Devices: Other legally marketed devices to which the current devices claim substantial equivalence.
- Regulatory Classification: Device class, product code, and classification panel.
The only mention of "Performance Data" is general: "Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." This statement indicates that some performance testing was carried out, but it doesn't describe the specific criteria, the study design, or the results of that testing.
Here's a breakdown of the requested information based on the provided text, with many fields necessarily marked as "Not provided" or "Not applicable":
Acceptance Criteria and Study Details for ETEX Bone Substitute Materials (K091729)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria (e.g., bone growth percentage, resorption rate within a certain timeframe, mechanical strength post-implantation, safety endpoints) | Not provided in the 510(k) summary. The document states "Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted," but does not detail the criteria or results. |
| Clinical Efficacy (e.g., successful defect filling, integration with host bone) | Not specifically quantified or reported as a performance metric with acceptance criteria in this document. The intended use implies successful defect filling and replacement with new bone, but no numerical targets are stated. |
| Safety (e.g., adverse event rates below a threshold) | Not specifically quantified or reported as a performance metric with acceptance criteria in this document. The substantial equivalence determination implies acceptable safety. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided.
- Data Provenance (Country of origin, retrospective/prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as a test set with expert-established ground truth for a performance study is not described in this document. The approval is based on substantial equivalence to predicate devices, supported by general performance testing per guidance documents.
4. Adjudication method for the test set
- Not applicable, as a test set requiring adjudication is not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a bone substitute material, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone substitute material.
7. The type of ground truth used
- Not applicable in the context of a diagnostic or AI performance study. For bone substitute materials, "ground truth" typically refers to histological analysis of bone formation, biomechanical testing, or clinical outcomes, but no details of such specific "ground truth" establishment are provided for a defined test set in this document.
8. The sample size for the training set
- Not applicable. This device is a bone substitute material. No mention of a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Performance Data Mentioned:
The document repeatedly states: "Performance Data: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted."
This indicates that the safety and effectiveness of the devices were supported by non-clinical (e.g., biocompatibility, physical properties, resorption characteristics) and potentially pre-clinical animal studies, as outlined in the referenced guidance document for bone grafting materials. However, the specific details of these tests, their acceptance criteria, and quantitative results are not included in this 510(k) summary. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that the new devices perform as safely and effectively as their predicates when used for their stated indications.
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5. 510(k) Summaries
DEC 2 3 2009
- 510(k) Summary Alpha-bsm 5.1
ETEX Corporation Submitter: 38 Sidney Street Cambridge, MA 02139 Registration No .: 1225112 Owner/Operator No .: 9014709
Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com
Date Prepared: June 9, 2009
Product Code(s): LYC (21 CFR 872.3930)
Device Class: II (21 CFR 872.3930)
Classification Panel: Dental
Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930)
Proprietary Name: Alpha-bsm Bone Substitute Material
Predicate Device(s): a-BSM Bone Substitute Material (ETEX Corporation, K962548 LYC Dental indication) a-BSM Bone Substitute Material (ETEX Corporation, K980223 LZK Maxillofacial indication) a-BSM Bone Substitute Material (ETEX Corporation, K983009 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K032307 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K072636 MQV Extremities, Pelvis and Spine indication) GRAFTON® DBM (Osteotech, K051188, NUN)
Device Description: Alpha-bsm Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a silicone bulb mixing system. The
Page 5-1 .
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resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Alpha-bsm Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Intended Use:
Alpha-bsm Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material nano-that forms a crystalline matix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Alpha-bsm Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, introral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects: craniofacial augmentation.
Materials: Synthetic calcium phosphate
Performance Data: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
{2}------------------------------------------------
510(k) Summary - Beta-bsm 5.2
| Submitter: | ETEX Corporation |
|---|---|
| 38 Sidney Street | |
| Cambridge, MA 02139 | |
| Registration No.: 1225112 | |
| Owner/Operator No.: 9014709 |
Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com
Date Prepared: June 9, 2009
Product Code(s): LYC (21 CFR 872.3930)
Device Class: II (21 CFR 872.3930)
Classification Panel: Dental
Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930)
Proprietarv Name: Beta-bsm Injectable Bone Substitute Material
Predicate Device(s): a-BSM Bone Substitute Material (ETEX Corporation, K962548 LYC Dental indication) a-BSM Bone Substitute Material (ETEX Corporation, K980223 LZK Maxillofacial indication) a-BSM Bone Substitute Material (ETEX Corporation, K983009 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K032307 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K072636 MOV Extremities, Pelvis and Spine indication) Beta-bsm Injectable Bone Substitute Material (ETEX Corporation, K090242) GRAFTON® DBM (Osteotech, K051188, NUN)
Device Description: Beta-bsm Injectable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a
{3}------------------------------------------------
paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Beta-bsm Iniectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects: alveolar ridge a augmentation (osteotomy. apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Materials: Synthetic calcium phosphate
Performance Data: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
Intended Use:
{4}------------------------------------------------
5.3 510(k) Summary - Gamma-bsm
| Submitter: | ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/Operator No.: 9014709 |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------- |
Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com
Date Prepared: June 9, 2009
Product Code(s): LYC (21 CFR 872.3930)
Device Class: II (21 CFR 872.3930)
Classification Panel: Dental
Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930)
Proprietary Name: Gamma-bsm Moldable Bone Substitute Material
Predicate Device(s): a-BSM Bone Substitute Material (ETEX Corporation, K962548 LYC Dental indication) a-BSM Bone Substitute Material (ETEX Corporation, K980223 LZK Maxillofacial indication) a-BSM Bone Substitute Material (ETEX Corporation, K983009 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K032307 GXP Cranioplasty indication) a-BSM Bone Substitute. Material (ETEX Corporation. K072636 MQV Extremities, Pelvis and Spine indication) Gamma-bsm Moldable Bone Substitute Material (ETEX Corporation, K090242) GRAFTON® DBM (Osteotech, K051188, NUN)
Device Description: Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a
{5}------------------------------------------------
putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate product, poorly crystalline material. The end hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural Gamma-bsm Moldable Bone Substitute bone minerals. Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Intended Use: Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects, These defects include, but are not limited to, periodontal/infrabony alveolar defects: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------(osteotomy. apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Materials: Synthetic calcium phosphate
- Performance Data: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
{6}------------------------------------------------
K0911729 Traditional 510(k) Submission –Bone Grafting Material
5.4 510(k) Summary - EquivaBone
| Submitter: | ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/Operator No.: 9014709 |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------- |
Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com
Date Prepared: June 9, 2009
Product Code(s): NUN (21 CFR 872.3930)
Device Class: II (21 CFR 872.3930)
Classification Panel: Dental
Classification Name: Bone Grafting Material, Human Source (21 CFR 872.3930)
Proprietary Name: EquivaBone Osteoinductive Bone Graft Substitute
Predicate Device(s): a-BSM Bone Substitute Material (ETEX Corporation, K962548 LYC Dental indication) a-BSM Bone Substitute Material (ETEX Corporation, K980223 LZK Maxillofacial indication) a-BSM Bone Substitute Material (ETEX Corporation, K983009 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K032307 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K072636 MQV Extremities, Pelvis and Spine indication) EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corporation, K080329 and K090310) GRAFTON® DBM (Osteotech, K051188, NUN)
Device Description: EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as
{7}------------------------------------------------
sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.
Intended Use: EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Osteoinductive Bone Graft Substitute is EquivaBone intended to be used in bony voids or gaps to fill and/or augment dental intraosseous. intraoral and maxillofacial These defects include, but are not limited to. defects. periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Materials: Synthetic calcium phosphate, sodium carboxymethyl cellulose, Demineralized Bone Matrix (DBM)
Performance Data: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Christopher Klaczyk Regulatory Affairs Manager ETEX Corporation 38 Sidney Street Cambridge, Massachusetts 02139
Re: K091729
Trade/Device Name: EquivaBone Osteoinductive Bone Graft Substitute Gamma-bsm Moldable Bone Substitute Material Beta-bsm Injectable Bone Substitute Material Alpha-bsm Bone Substitute Material
DEC 2 3 2009
Regulation Number: 21CFR 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: II
Product Code: LYC, NUN
Dated: December 9, 2009
Received: December 10, 2009
Dear Mr. Klaczyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{9}------------------------------------------------
Page 2- Mr. Klaczyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
. Anton V. Maier
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
4.4 Indications For Use - EquivaBone
510(k) Number (if known): K091729
Device Name:
EquivaBone Osteoinductive Bone Graft Substitute
Indications for Use:
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use (Part 21 CFR 801 Subpart D)
. AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Th
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091729
{11}------------------------------------------------
4. Indications For Use
Indications For Use - Alpha-bsm 4.1
K091729 510(k) Number (if known):
Device Name:
Alpha-bsm Bone Substitute Material
Indications for Use:
Alpha-bsm Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Alpha-bsm Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jh
Division Sian-Off Division of Anesthesialogy, General Ho Infection Control. Dental Devices
510(k) Number: K091729
{12}------------------------------------------------
4.3 Indications For Use - Gamma-bsm
K091729 510(k) Number (if known):
Device Name:
Gamma-bsm Moldable Bone Substitute Material
Indications for Use:
Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectorny, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
h
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091729
{13}------------------------------------------------
Indications For Use - Beta-bsm 4.2
K09 j729
510(k) Number (if known): K091729
Device Name:
Beta-bsm Injectable Bone Substitute Material
Indications for Use:
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectorny, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Kinh
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number
§ 872.3930 Bone grafting material.
(a)
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.(b)
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.