(106 days)
No
The summary describes a bone grafting material and a barrier material, focusing on their physical properties, composition, and intended use in dental procedures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is a bone grafting material and a space-maintaining barrier for dental extraction sockets, which aids in regeneration and healing but does not directly treat a disease or cure a condition.
No
The device, SOCKET GRAFT, is a bone grafting material intended to regenerate bone, and Socket Seal is a barrier material. Neither of these descriptions indicates a diagnostic function; they are therapeutic and protective.
No
The device description clearly states that the device is a "dual phase calcium phosphate biocement" and a "polyethylene foam material," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a bone grafting material and a temporary barrier for use in dental extraction sockets and the oral cavity. These are therapeutic and structural applications, not diagnostic ones.
- Device Description: The description details the physical composition and function of the materials (calcium phosphate biocement and polyethylene foam) for bone regeneration and space maintenance. This aligns with a medical device used for treatment or support, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) to provide information about a patient's health status or disease.
- Performance Studies: The performance studies described focus on material properties and comparison to a predicate device, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
In summary, the device's purpose is to facilitate bone healing and provide a barrier in a surgical context, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
Product codes (comma separated list FDA assigned to the subject device)
LYC, NPK
Device Description
SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes.
Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental extraction sockets, oral cavity, maxilla and mandible
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 testing was performed comparing Socket Graft K113049 to Socket Graft K052493. Differences in composition were noted, specifically the addition of sodium salt of carboxymethylcellulose in K113049. This addition is consistent with GRAS classification 21 CFR 182.1745. The performance characteristics for K113049 were found to be comparable to the predicate regarding trace impurities, particles, Ca/P ratio, pH, volumetric porosity, and solubility. The predicate device Socket Graft K052493 was shown to fully resorb in 12-14 weeks. Published research on the predicate device's healing time for implant placement (6 weeks for incisors and bicuspids, 8 weeks for molars) supports the earliest implant placement for Socket Graft K113049 at 8 weeks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052493, K090855, K041324, K974752, K965205
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
SUMMARY REPORT
JAN 2 7 2012
SUBMITTED BY
Gregory Gene Steiner CEO STEINER LABORATORIES Kapolei, HI 96707 808 689 1710
01/15/2012
This summary of 510k substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92. Socket Graft is intended to be marketed as a kit containing Socket Graft bone grafting material and a barrier membrane titled Socket Seal.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME for Socket Graft
| Classification Name: | Bone grafting material, synthetic |
|---|---|
| Common/Usual Name: | Bone grafting material |
| Product Classification: | LYC |
| Proprietary Name: | SOCKET GRAFT |
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME for Socket Seal
| Classification Name: | Barrier, Synthetic, Oral |
|---|---|
| Regulation description: | Bone grafting material |
| Common/Usual Name: | Barrier, Synthetic, Oral |
| Product Classification: | NPK |
| Proprietary Name: | SOCKET SEAL |
SOCKET GRAFT grafting material is substantially equivalent to:
-
- Socket Graft K052493
-
- EquivaBone Osteoinductive Bone Graft K090855
-
- CalMatrix Calcium Sulfate Bone Graft K041324
SOCKET SEAL is substantially equivalent to:
1
DEVICE DESCRIPTION
SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes.
Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.
INDICATIONS FOR USE
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining.
Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
PERFORMANCE TESTING:
In comparison to the predicate device Socket Graft K052493comparison summary: Non clinical testing.
| Socket Graft predicate K052493 | Socket Graft K113049 | |
|---|---|---|
| Trace impurities analysis | ||
| Reference US pharmacopeia 34 | ||
| specification NMT 20 PPM | pass | pass |
| Particles | none | none |
| Ca/P ratio | equivalent | equivalent |
| Ph | 7.2 | 7.4 |
| volumetric | ||
| porosity | 25% | non porous |
| Solubility @ 20C | non soluble | non soluble |
2
The proposed device Socket Graft K113049 differs in composition only by the addition of sodium salt of carboxymethylcellulose.
The sodium salt of carboxymethylcellulose used in Socket Graft conforms to the GRAS classification 21 CFR 182.1745 with the following analysis:
| reference | test results |
|---|---|
| 99.5% by dry weight | 99.8 |
| max substitution 0.95 | 0.77 |
| minimum viscosity 25 centipoises | 3100 centipoises |
Predicate devices EquivaBone Osteoinductive Bone Graft and CalMatrix Calcium Sulfate Bone Graft both contain comparable amounts of carboxymethylcellulose and both of these predicate devices have used carboxymethylcellulose to increase the viscosity of their graft material in the same manner as the proposed device Socket Graft K113049 . Carboxymethylcellulose has been shown to resorb in 12 weeks in vivo in the following reference "Carboxymethylcellulose-stabilized collagenous rhOP-1 device-a novel carrier biomaterial for the repair of mandibular continuity defects. Wang H et al".
The predicate device Socket Graft K052493 was shown to fully resorb in 12-14 weeks. The timing of implant placement for Socket Graft K113049 is based on published research for the predicate device Socket Graft K052493. In the published research article "The healing socket and socket regeneration. Compend Contin Educ Dent. 2008 Mar;29(2):114-6, 118, 120-4". One Hundred implants were placed on a protocol of 6 weeks for incisors and bicuspids and 8 weeks for molars. All one hundreds implants integrated and all implants were in function 3 years after placement. Therefore, the earliest time point for implant placement in sockets grafted with Socket Graft K113049 is 8 weeks.
Substantial Equivalence:
Socket graft grafting material and Socket Seal shares indications and design principles with the following predicate devices:
| Device name | Proposed Device | Predicate device #1 | Predicate Device #2 | Predicate Device #3 |
|---|---|---|---|---|
| Socket Graft | Socket Graft | EquivaBone | ||
| Osteoinductive Bone | ||||
| Graft | CalMatrix Calcium | |||
| Sulfate Bone Graft | ||||
| 510 K number | K113049 | K052493 | K090855 | K041324 |
| Intended use | SOCKET GRAFT is a | |||
| bone grafting material | SOCKET GRAFT is a | |||
| bone grafting material | EquivaBone is an | |||
| osteoinductive bone | used to treat multiple | |||
| types of maxillary and |
3
| | indicated for use in
dental extraction
sockets that have all
walls remaining. | indicated for use in
dental extraction
sockets. | graft substitute that
is resorbed and
replaced with new
bone during the healing
process. It is intended
for use to fill bony
voids or gaps of the
skeletal system of the
extremities, spine
(i.e.posterolateral
spine) and pelvis that
are not intrinsic to the
stability of the bony
structure. These voids
or gaps may result from
natural occurring bone
disease, traumatic
injury
or surgical intervention. | mandibular osseous
and periodontal defects
such as:
Intrabony/infrabony
defects, furcation
defects, recession
defects,
dehiscence/fenestratio
n defects (natural teeth
and prosthetic root
form implants),
extraction socket (ridge
preservation) defects,
ridge augmentation
defects, sinus lift
defects, endodontic
bony defects |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | A dual phase calcium
phosphate biocement
plus carboxymethyl
cellulose
(CMC) that is wetted by
sterile water to a putty
consistency. | A dual phase calcium
phosphate biocement
that is wetted by
sterile water to a paste
consistency | Synthetic calcium
phosphate,
carboxymethyl
cellulose
(CMC) and
demineralized bone
matrix (DBM) that is
wetted by sterile water
to a putty consistency. | A calcium sulfate
material that contains
approximately 10% of
pharmaceutical grade
sodium
carboxymethylcellulose
(CMC) that is wetted by
sterile water to a putty
consistency. |
| Design | Powder, water | Powder, water | Powder, water | Powder, water |
| Sterile/
non sterile | Sterile | sterile | Sterile | Sterile |
| Sterilization
method | gamma | gamma | gamma | gamma |
| Biocompatible | Yes | yes | yes | yes |
| Resorbable/
Nonresorbable | resorbable | resorbable | resorbable | resorbable |
PREDICATE DEVICES for Socket Seal
:
| Device name | Proposed Device | Predicate Device #1 | Predicate Device#2 |
|---|---|---|---|
| Socket Seal | IMTEC BioBarrier | ||
| Membrane | Tefgen-LS | ||
| 510 K number | K113049 | K974752 | K965205 |
| Intended use | A temporary | ||
| implantable material | |||
| intended for use in the | |||
| oral cavity to be used as | A temporary implantable | ||
| material intended to be | |||
| used in the oral cavity as a | |||
| space maintaining barrier | A implant material which is | ||
| intended to be used in the | |||
| oral cavity as a temporary | |||
| space making barrier over |
4
| | a space maintaining
barrier over bone and
connective tissue.
Socket Seal is indicated
for use over bone
grafts. Socket Seal in
indicated for use over
extraction sockets in
the maxilla and
mandible. | over bone. Use in
augmentation around
implants placed in
immediate extraction
sockets and around
implants placed in delayed
extraction sockets and
should be used in
combination with space-
making bone graft
material. | bone or other tissue. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Material | polyethylene | polyethylene | polyethylene |
| Design | sheets | sheets | sheets |
| Sterile/non
sterile | Sterile | Sterile | Sterile |
| Sterilization
method | gamma | Not specified | Not specified |
| Biocompatible | Yes | yes | yes |
| Resorbable/
Nonresorbable | nonresorbable | nonresorbable | nonresorbable |
| porosity | nonporous | nonporous | nonporous |
Conclusion (statement of equivalence)
The data submitted in this 510(k) supports substantial equivalence of Socket Graft and Socket Seal to the following aforementioned commercially marketed devices.
Substantial equivalence is based on the indications for use, product design and configuration, and materials used. The intended use of Socket Graft K113049 is the same as Socket Graft K052493, and the materials used are the same as those found in Socket Graft K052493 with the exception of the addition of carboxymethyl cellulose(CMC). Socket The comparative analysis demonstrates the substantial equivalence of Socket Graft and Socket Seal to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory G. Steiner CEO STEINER LABORATORIES 590 Farrington Highway, #524 Suite 132 Kapolei, Hawaii 96707
Re: K113049
Trade/Device Name: Socket Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 15, 2012 . Received: January 23, 2012
Dear Mr. Steiner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
JAN 2 7 2012
6
Page 2 - Mr. Steiner
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
G for Anthony Watson
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
7
Indications for Use Statement
| 510(k) Number (if known) | K113049, Socket Graft, January 15 2012 |
|---|---|
| Device Name | Socket Graft |
| Indications for Use | SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible." |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
Prescription Use_ X (Per 21 CFR 801. 109)
Over-The-Counter Use_
Susan Kunne
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KII13049 510(k) Number: __