(66 days)
Not Found
No
The device description and intended use focus solely on the material properties and physical application of bone graft substitutes. There is no mention of any computational or analytical functions that would typically involve AI/ML.
Yes
The device is a bone substitute material intended to fill and/or augment bone voids, gaps, or defects, which directly contributes to the healing process and restoration of bone structure.
No
The device is a bone substitute material used for filling and/or augmentation of bone voids, gaps, or defects. Its intended use is for treatment and repair, not for diagnosing conditions.
No
The device description clearly outlines physical components (powder, mixing solution, syringe-to-syringe mixing system, putty) that are mixed and implanted, indicating it is a physical medical device, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these devices are "implantable synthetic calcium phosphate bone graft material" used for "filling and/or augmentation of bone voids, gaps or defects." This describes a material that is surgically placed within the body to promote bone healing.
- Device Description: The device description details the composition and how the material is prepared and applied in-situ (within the body) to harden and be replaced by natural bone.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens outside the body.
These devices are clearly intended for direct implantation into the body for therapeutic purposes related to bone repair, which is not the function of an IVD.
N/A
Intended Use / 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 include, defects 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 defects; alveolar ridge augmentation (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 resorb 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.
Product codes
LYC, 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 paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site under direct visualization using the syringe 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone voids, gaps or defects that are not intrinsic to the stability of the bony structure; dental intraosseous, intraoral and maxillofacial defects; periodontal/infrabony defects; alveolar ridge; dental extraction sites; sinus; craniofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
Clinical Test: Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices.
Conclusions: Based upon our assessment of the performance data, the revised device is safe and effective for its intended use and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Beta-bsm Injectable Bone Substitute Material (cleared for Dental and Maxillofacial indications per K091729), Beta-bsm Injectable Bone Substitute Material (alternate Hydration Solution cleared for Orthopedic indications per K101557), Gamma-bsm Moldable Bone Substitute Material (cleared for Dental and Maxillofacial indications per K091729), Gamma-bsm Moldable Bone Substitute Material (alternate Hydration Solution cleared for Orthopedic indications per K101557), EquivaBone Osteoinductive Bone Graft Substitute (cleared for Dental and Maxillofacial indications per K091729), EquivaBone Osteoinductive Bone Graft Substitute (alternate Hydration Solution cleared for Orthopedic indications per K101557)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
0 = 3 = 3 = 2010
Special 510(k) Submission - Alternate Hydration Solution
5. 510(k) Summary
- 5.1 510(k) Summary - Beta-bsm
| Submitter: | ETEX Corporation |
|---|---|
| 38 Sidney Street | |
| Cambridge, MA 02139 | |
| Registration No.: | 1225112 |
| Owner/Operator No.: | 9014709 |
Christopher Klaczyk Contact Person: Regulatory Affairs Manager (617) 577-7270 x160 Office: Mobile: (617) 710-8091 (617) 577-7170 Fax: cklaczyk@etexcorp.com E-Mail:
Date Prepared: September 27, 2010
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: Beta-bsm Injectable Bone Substitute Material
Predicate Device(s): Beta-bsm Injectable Bone Substitute Material (cleared for Dental and Maxillofacial indications per K091729) Beta-bsm Injectable Bone Substitute Material (alternate Hydration Solution cleared for Orthopedic indications per K101557)
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 paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site under direct visualization using the syringe 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
ETEX Corporation
Page 5-1
1
Special 510(k) Submission - Alternate Hydration Solution
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.
Intended 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 include, defects ---------------------------------------------------------------------------------------------------------------------------------------------------------------------to. periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Technological Characteristics:
| Characteristic | Subject | Predicate |
|---|---|---|
| Biomaterial | Proprietary calcium phosphate formula | Proprietary calcium phosphate formula |
| Hydration Media | ||
| (provided) | 0.9% sodium chloride | |
| solution conforming | ||
| with the monograph | ||
| for 0.9% Sodium | ||
| Chloride Injection | ||
| USP | 0.9% Sodium | |
| Chloride Injection | ||
| USP | ||
| Hydration Media | ||
| (not provided) | None | None |
| Sterilization | Gamma irradiation | Gamma irradiation |
Materials:
Synthetic calcium phosphate
Non-Clinical Test:
Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
2
Special 510(k) Submission -- Alternate Hydration Solution
Clinical Test: Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices.
Based upon our assessment of the performance data, the Conclusions: revised device is safe and effective for its intended use and performs as well as the predicate device.
3
Klo2812
ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
Special 510(k) Submission - Alternate Hydration Solution
510(k) Summary - Gamma-bsm 5.2
| Submitter: | ETEX Corporation
38 Sidney Street
Cambridge, MA 02139
Registration No.: 1225112
Owner/Operator No.: 9014709 | DEC - 3 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------- | --------- |
|---|
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: September 27, 2010
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): Gamma-bsm Moldable Bone Substitute Material (cleared for Dental and Maxillofacial indications per K091729) Gamma-bsm Moldable Bone Substitute Material (alternate Hydration Solution cleared for Orthopedic indications per K101557)
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 aTraditional 510(k) Submission -- Bone Grafting Material 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
4
Special 510(k) Submission - Alternate Hydration Solution
bone minerals. Gamma-bsm Moldable Bone Substitute 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 defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Technological Characteristics:
| Characteristic | Subject | Predicate |
|---|---|---|
| Biomaterial | Proprietary calcium | |
| phosphate formula | Proprietary calcium | |
| phosphate formula | ||
| Hydration Media | ||
| (provided) | 0.9% sodium chloride | |
| solution conforming | ||
| with the monograph | ||
| for 0.9% Sodium | ||
| Chloride Injection | ||
| USP | 0.9% Sodium | |
| Chloride Injection | ||
| USP | ||
| Hydration Media | ||
| (not provided) | Autologous whole | |
| blood, autologous | ||
| bone marrow aspirate | Autologous whole | |
| blood, autologous | ||
| bone marrow aspirate | ||
| Sterilization | Gamma irradiation | Gamma irradiation |
Materials: Synthetic calcium phosphate
Non-Clinical Test: Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
Clinical Test:
Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices.
5
Special 510(k) Submission – Alternate Hydration Solution
Conclusions:
Based upon our assessment of the performance data, the revised device is safe and effective for its intended use and performs as well as the predicate device.
:
6
Special 510(k) Submission – Alternate Hydration Solution
5.3 510(k) Summary – EquivaBone
| Submitter: | ETEX Corporation
38 Sidney Street
Cambridge, MA 02139
Registration No.: 1225112
Owner/Operator No.: 9014709 | DEC - 3 2010 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 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: | September 27, 2010 | |
| 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): | EquivaBone Osteoinductive Bone Graft Substitute (cleared
for Dental and Maxillofacial indications per K091729)
EquivaBone Osteoinductive Bone Graft Substitute
(alternate Hydration Solution cleared for Orthopedic
indications per K101557) | |
| 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
Traditional 510(k) Submission -Bone Grafting Material
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. | |
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
·
.
.
.
Page 5-7
:
:
.
.
7
- 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.
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.
Technological Characteristics:
| Characteristic | Subject | Predicate |
|---|---|---|
| Biomaterial | Proprietary calcium | |
| phosphate formula, | ||
| carboxymethyl | ||
| cellulose (CMC), | ||
| demineralized bone | ||
| matrix (DBM) | Proprietary calcium | |
| phosphate formula, | ||
| carboxymethyl | ||
| cellulose (CMC), | ||
| demineralized bone | ||
| matrix (DBM) | ||
| Hydration Media | ||
| (provided) | 0.9% sodium chloride | |
| solution conforming | ||
| with the monograph | ||
| for 0.9% Sodium | ||
| Chloride Injection | ||
| USP | 0.9% Sodium | |
| Chloride Injection | ||
| USP | ||
| Hydration Media | ||
| (not provided) | Autologous whole | |
| blood, autologous | ||
| bone marrow aspirate | Autologous whole | |
| blood, autologous | ||
| bone marrow aspirate | ||
| Sterilization | Gamma irradiation | Gamma irradiation |
Materials:
Synthetic calcium phosphate, sodium carboxymethyl cellulose (CMC) and demineralized bone matrix (DBM)
Non-Clinical Test:
Testing consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
and the comments of the comments of the comments of
8
Special 510(k) Submission – Alternate Hydration Solution
Clinical Test: Per Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005), clinical testing is not required for the subject devices. Conclusions: Based upon our assessment of the performance data, the revised device is safe and effective for its intended use and
performs as well as the predicate device.
9
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is rendered in blue and consists of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Christopher Klaczyk Regulatory Affairs Manager ETEX Corporation 38 Sidney Street Cambridge, Massachusetts 02139
JAN 1 2 2011
Re: K102812
Trade/Device Name: Beta-bsm Injectable Bone Substitute Material Gamma-bsm Moldable Bone Substitute Material EquivaBone Osteoinductive Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN, LYC Dated: November 3, 2010 Received: November 5, 2010
Dear Mr. Klaczyk:
This letter corrects our substantially equivalent letter of December 3, 2010.
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 (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.
10
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.
for
Anthony 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
11
Special 510(k) Submission - Alternate Hydration Solution
4. Indications For Use
4.1 Indications For Use - Beta-bsm
11/02812 510(k) Number (if known):
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, 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)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospi. Infection Control and Dental Devices | |
| 510(k) Number: | K140282 |
12
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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . . スティース - 1 ਾ ਦੇ ਸੰਬਰ ਦੇ ਸਮੇਂ ਦ ਸਾਲ ਵਿੱਚ ਸਾਰਕ ਸਾਰੀ ਦਾ ਸਾਰੀ ਕਰ ਸਾਰੀ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸੰਗ 11 11:1 00-11-2017 11:00:00 来源: ಾರ್ ಅಥವಾ ಸಾಮಿತ್ಯ ಸಿಜಯ ಮಹಾರಾಯ ಚಿತ್ರಿಕೆಯ te in the varieten திருக்கு விளைவிடம் இருக்கும் இருக்கும் இது முறைக . and and the first of the state
ਾ ਦੀ ਸਾਹਿਤ ਕਿ ਸਾਰੇ ਦੇ ਸਿੰਘ ਸੀ। a marka masa da katika masa mandu ara : : िक्स के समुद्री के साथ की मानवान के साथ से समय में बाद में बाद में बाद में बाद में बाद में बाद में बाद में बाद में कि में बाद में कि में बाद में कि में बाद में कि में बाद मे : . m on the final comments of the production of the comments of the : ..... ಿ ಸಿಂದಿಸಿದ ಹಿಂದೆ ಮಾರ್ ಅವರಿಗೆ ಮಾರ್ ಮತ್ತು ಒಂದು ಮಾರ್ ಅಂದರ್ ಅಂದು ಪ್ರಾ . . . . . .
and the same of the same of the same of the secure of
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13
4.2 Indications For Use - Gamma-bsm
1102812 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 defecto. 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 Deyice Evaluation (ODE)
Susan Kenaus
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K2812
14
agared Printers - Bal . 9 11 11 1 . . . . . . . . . . . . . .
1 1 1 1 1 1 1 1 1 1 1 1 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
11 2011 11:11
317 Schl and and the province and
: e manager and comments of the
e general de la provinsion in de comment de la program discussi ය කියන පිහිටා අනුව අධිකානු විය. i respect production and political considere contrasse consideration Children Children : मुंबई के बाद में समस्या कर रहे हैं कि मिल के बाद में कि मिली है कि में बना दे कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि osten opera programade and sommercial programment proposes e voël ogste e komunistry versi me namerika
ക്കുന്നു. അവലംബം ಾರ್ - ਹੈ ਅਤੇ ਇਸ ਨੇ ਮੈਨੀਆਂ ਦੇ ਸ਼ਹਿਰ ਅਤੇ ਪਾਰਟ ਕਰ ਦਾ ਹੈ ਅਨੁਸਾਰ ਦੇ ਵਾਲੀ ਸ਼ੁਰੂਆਂ ਦੀ ਮਾਰਤ ਦੀ ਸਾਰੀ ਦੇ ਸਾਰ gris Frances of the production and province of the provided to and the p ് വേണ്ടി വിവിധ വിവിധ വിവിധ വിശ്വാഭ്യമായ വാഹിത്രക്രി എന്ന വിവരുവിന്റെയും വിക്കുന്നത്. ் ஆவது முறைய நக .
ਸੀ। ਦੀ ਸਾਹਿਤ ਮਾਲਕ ਦਾ ਸਾਲ ਪਿਆ ਸਿੰਘ ਸਿਰਮ ਲਾਈ ਦੀ ਦੇ ਪਿੰਡ ਬਣਾ 1 11:50:1
ਦੀ ਕਰ ਦੇ ਮਾਰਕ ਦਾ ਸੁਰੂ ਇੱਕ ਸੂਬਿਆ ਸੀ। ਉਸਦਾ ਸੀ। ਉਹ ਸਾਰਕ ਦਾ ਸਾਰ ਪਿੰਡ
. President (1) -
" art the for start in
2019 - 19:00 (MO-argi2 noizivi(I) .............................................................................................................................................................................. 2017 2017/06/1 Introd has lound online 3 notiso 201 alle 13dmin (1)012
ਸ ਕਿ ਸਾਰਕ ਕਿਸਮ 12
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11:12:18
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15
4.3 Indications For Use - EquivaBone
R102812 510(k) Number (if known):
EquivaBone Osteoinductive Bone Graft Substitute
Indications for Use:
Device Name:
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 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control and Dental Devices | |
| 510(k) Number: |
16
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