(97 days)
No
The device description and performance studies focus on the material properties and physical performance of a bioceramic paste, with no mention of AI or ML.
Yes
The device is a root repair paste intended for permanent root canal repair, apexification, and pulp capping, all of which are therapeutic interventions.
No.
The device description and intended use clearly indicate that Vista BC Putty is a root repair paste used for therapeutic procedures (e.g., repairing root perforation, apexification, pulp capping), not for diagnosing conditions.
No
The device description clearly states that Vista BC Putty is a physical material (paste) packaged in a syringe, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health. Examples include blood tests, urine tests, and tissue biopsies.
- Vista BC Putty is a material used for direct treatment within the body. It is a root repair paste applied directly to the root canal system for various dental procedures. It is not used to analyze a sample taken from the patient.
The description clearly states its intended use is for procedures like repairing root perforations, root resorption, root end filling, apexification, and pulp capping. These are all therapeutic interventions performed directly on the patient's tooth structure.
N/A
Intended Use / Indications for Use
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
Product codes
KIF
Device Description
Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity - root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental and Endodontic offices
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
Non-Clinical Performance Testing and Compliance:
- ISO 6876 Testing: Benchtop testing on Vista BC Putty was completed following ISO 6876 test protocols for set time, film thickness, solubility and disintegration, and radiopacity. Vista BC Putty was compared to the predicate device (MTA 2.3 (Design 2)) and reference device #1 (iRoot FS). Testing confirmed the substantial equivalence of the subject device to the predicate device.
- Shelf-Life Testing: Through accelerated shelf-life testing, Vista BC Putty was found to have a shelf-life of two years. Real time aging is being performed on Vista BC Putty to support shelf life during typical storage conditions.
- Transit Testing: This test confirms that the packaging configurations are sufficient and withstand simulated transit conditions. Moreover, the products performed satisfactory post-transit, which confirms that transit did not have a negative effect on the products themselves.
- Microbiological Testing: Contamination risks from manufacturing are mitigated as Vista BC Putty exhibits antimicrobial properties. Furthermore, these results help to support shelf stability and multiple use of non-patient contacting materials, such as the syringes, as any introduced microbes will not remain viable within the medical device.
- Cytotoxicity Testing: Vista BC Putty was found to yield better cytotoxicity results compared to the reference device, Vista BC Sealer.
Clinical Performance Testing and Compliance: Clinical performance is not deemed necessary.
Key Metrics
Not Found
Predicate Device(s)
MTA 2.3 (Design 2) (K181917)
Reference Device(s)
iRoot FS (K102867), Vista BC Sealer (K221811)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 28, 2024
Inter-Med, Inc. Alex Johnson VP of Engineering, Regulatory & Ouality 2200 South Street Racine, Wisconsin 53404
Re: K241457
Trade/Device Name: Vista BC Putty Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: Mav 22, 2024 Received: May 23, 2024
Dear Alex Johnson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha. MChE, RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
2
Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K241457
Device Name
Vista BC Putty
Indications for Use (Describe)
- · Repair of Root Perforation
- · Repair of Root Resorption
- · Root End Filling
- · Apexification
- · Pulp Capping
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue font and is underlined by a thin black line. To the right of the word is a blue globe with white lines depicting longitude and latitude. The letters "INC." are in black font to the right of the globe.
Image /page/4/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a light blue sans-serif font, with a stylized mountain range above it. Below the word "VISTA" are the words "Dental Products" in a smaller, sans-serif font. There is a horizontal line to the left of the word "VISTA".
510(k) Summary for Vista BC Putty
1. Applicant
Alex Johnson Submitter's Name: Khongchee Xiong Date Summary Prepared: March 28, 2024
Address: Inter-Med, Inc. / Vista Apex 2200 South St. Racine, WI, USA 53404
Contact Person: Alex Johnson, MSc
Email: ajohnson@vista-dental.com
Phone: (262) 631-5306
Fax: (262) 636-9760
2. Device Name
Proprietary Name: Vista BC Putty Common Name: Root canal filling material Product Code: KIF Device Class: Class 2
3. Predicate Device
Primary Predicate Device MTA 2.3 (Design 2) by Avalon Biomed, Inc.
- o Common Name: Root canal filling material
- Product Code: KIF O
- Device Class: Class 2 O
Reference Device #1 iRoot FS by Innovative BioCeramix, Inc.
- Common Name: Root canal filling material о
- O Product Code: KIF
5
Image /page/5/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue font, with a black line underneath. To the right of the word is a blue globe, and to the right of the globe is the word "INC." in black font.
Image /page/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a large, sans-serif font, with a stylized mountain range above it. Below the word "VISTA" are the words "Dental Products" in a smaller font. The logo is primarily blue and black.
-
Device Class: Class 2 o
Reference Device #2 Vista BC Sealer (K221811) by Inter-Med, Inc. -
Common Name: Root canal filling material O
-
Product Code: KIF o
-
Device Class: Class 2 O
Device Description 4.
Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.
This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.
ನ. Intended Use / Indication for Use
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling ●
- Apexification ●
- Pulp Capping ●
Technological Characteristics and Substantial Equivalence 6.
| Characteristic | Proposed Device | Predicate Device | Reference Device
#1 | Reference Device
#2 |
|----------------|--------------------------------------------------------------|--------------------|------------------------|------------------------|
| 510(k) Number | Pending
(subject device for
this 510(k)
submission) | (K181917) | (K102867) | (K221811) |
| Common Name | Root Canal Filling | Root Canal Filling | Root Canal Filling | Root Canal Filling |
| Product Code | KIF | KIF | KIF | KIF |
| Trade Name | Vista BC Putty | MTA 2.3 (Design 2) | iRoot FS | Vista BC Sealer |
6
Image /page/6/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a horizontal line underneath. To the right of the word is a blue globe, and to the right of the globe is the word "INC."
Image /page/6/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller font. The logo is in a light blue color.
| Manufacturer | Inter-Med, Inc. | Avalon Biomed | Innovative
BioCeramix, Inc. | Inter-Med, Inc. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | Vistas BC Putty is a
hydraulic, ready-to-
use injectable
bioceramic, bioactive
root repair paste
developed for
permanent root canal
repair of root
perforation and root
resorption, and root
end filling,
apexification and
pulp capping
applications. | The MTA2.3 ROOT
& PULP
MATERIALS are
designed and
developed for dental
clinicians to
use in contact with
vital pulp tissue and
periradicular tissue,
including sealing
and
obturation of root
canals. The
materials can be
used for dental
procedures
contacting
pulpal or
periradicular tissue
such as: pulp
capping, cavity
lining, base material
in a cavity,
pulpotomies, root-
end filling,
apexification,
perforation repair,
root resorption, and
obturation
(pulpectomy)
including root canal
sealing. | iRoot FS Injectable
Root Canal Repair
Filling Material is a
convenient ready-
to-use fast setting
white hydraulic
premixed
bioceramic pasted
developed for
permanent root
canal repair of root
perforation and root
resorption, and root
end filling,
apexification and
pulp capping
applications. | Vista BC Sealer is a
ready-to-use
injectable white
hydraulic cement
paste suitable for
permanent root
canal filling and
sealing of the entire
root canal. |
| Intended | Dental and | Dental and | Dental and | Dental and |
| population
Anatomical Site | Endodontic offices
Oral Cavity - root
canal | Endodontic offices
Oral Cavity - root
canal | Endodontic offices
Oral Cavity - root
canal | Endodontic offices
Oral Cavity - root
canal |
| Composition (bold
text added to
highlight
similarities in
composition
between subject
device and
predicate /
reference devices) | Cementing agents,
Radiopacifier,
Calcium sodium
phosphosilicate,
Calcium Sulfate,
Tricalcium
Phosphate,
Thickening agent,
Filler, Carrier | Tantalite
Tricalcium Silicate
Calcium Aluminate
Dicalcium Silicate
Tricalcium
aluminate
Calcium Sulfate,
Thickening agent
Filler, Carrier | Tricalcium silicate
Dicalcium silicate
Calcium
phosphate
monobasic
Zirconium oxide
Tantalum Pentoxide
Filler, Carrier | Calcium
aluminates.
Radiopacifier,
Calcium sodium
phosphosilicate,
Thickening agent,
Accelerator,
Filler, Carrier |
| Principle of
operation | Vista BC Putty is an
insoluble,
radiopaque,
hydraulic cement
material that absorbs
the moisture already
present in the
surrounding tissues
of the root canal to
set and solidify. | The MTA 2.3
ROOT & PUMP
MATERIALS
(design 2) is placed
in the space created
by the procedure and
set in vivo . The
mechanism of action
is setting of the
inorganic,
ceramic cement in
the presence of the
water-based body
fluids present in
teeth. | iRoot FS is an
insoluble,
radiopaque and
aluminum free
material based on a
calcium silicate
composition, which
requires the
presence of
water to set and
harden. | Vista's BC Sealer is
an insoluble and
radiopaque root
canal sealer which
requires the
presence of water to
set and harden.
Upon placement of
material into the
root canal, the
moisture present
from surrounding
tissues helps to
initiate a setting
reaction within the
material and
eventually
solidifying into a
hard structure. |
| Indications for
use | Repair of Root
Perforation
Repair of Root
Resorption
Root End Filling
Apexification
Pulp Capping | Repair of Root
Perforation
Repair of Root
Resorption
Root End Filling
Apexification
Pulp Capping | Repair of Root
Perforation
Repair of Root
Resorption
Root End Filling
Apexification
Pulp Capping | Permanent
obturation of the
root canal following
root canal
treatment. |
| Delivery form | Single paste | Single paste | Single paste | Single paste |
| Design | Pre-loaded syringe | Pre-loaded syringe | Pre-loaded syringe | Pre-loaded syringe,
Disposable Intra
Canal Tips |
| Nature of Contact
(ISO 7405:2018) | Category: External
communicating
device
Contact: Tissue,
bone and dentin
Contact Duration: C
- Permanent
(>30 days) | Category: External
communicating
device
Contact: Tissue,
bone and dentin
Contact Duration: C - Permanent
(>30 days) | Category: External
communicating
device
Contact: Tissue, bone and
dentin Contact
Duration: C -
Permanent (>30
days) | Category: External
communicating
device
Contact: Tissue,
bone and dentin
Contact Duration: C - Permanent
(>30 days) |
| Set Time | ≤ 90 minutes | 30 days) contact per ISO 7405:2018. - Vista BC Putty composition consists of similar ingredicate device (MTA 2.3 ● (Design 2)) and reference devices. In fact, Vista BC Putty consists of all the same ingredients at slightly different ratios, except an accelerator, as reference device #2 (Vista BC Sealer). A further detailed explanation is provided within the 510(k) Section 12 - Substantial Equivalence Discussion.
- o The differences in composition do not raise any concerns as biocompatibility testing confirms the product is biocompatible for its intended use.
- Vista BC Putty's shelf life of two years is similar to the predicate device (MTA 2.3 (Design ● 2)) and identical to the reference devices.
- Identical to the predicate device (MTA 2.3 (Design 2)) and reference devices, Vista BC Putty ● is a non-aqueous paste-like material that is commercialized non-sterile.
- Identical to the predicate device (MTA 2.3 (Design 2)) and reference devices, Vista BC Putty ● is for prescription use (Rx) only.
Vista BC Putty shares similar intended use, technical characteristics, and composition to the predicate and reference devices. Therefore, Vista BC Putty is substantially equivalent to the predicate device and poses no additional safety or efficacy risks.
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Image /page/9/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a blue globe to the right of the word. The letters "INC." are in black and to the right of the globe. There is a black line underneath the word "intermed".
Image /page/9/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. To the right of the word "VISTA" is the trademark symbol. Below the word "VISTA" is the phrase "Dental Products".
Discussion of Differences between the subject device (Vista BC Putty) and the predicate device (MTA 2.3 (Design 2)) as well as reference device #1 (iRoot FS) and reference device #2 (Vista BC Sealer).
- The formulation of Vista BC Putty is different than the predicate device (MTA 2.3 (Design 2)) . and reference device (MTA 2.3 (Design 2)).
- o A further detailed explanation is provided within the 510(k) Section 12 Substantial Equivalence Discussion. However, the differences in composition do not raise any concerns as biocompatibility testing confirms the product is biocompatible for its intended use.
- Additionally, Vista BC Putty consists of all the same ingredients at slightly different O ratios, except an accelerator, as reference device #2 (Vista BC Sealer).
- Therefore, the subject device remains substantially equivalent to its predicate device. O
- Vista BC Putty has a shorter set time compared to the predicate device (MTA 2.3 (Design 2)). ●
- This does not raise any concerns as both materials set on the order of tens to hundreds of O minutes and permanently remains within the root canal. Additionally, both reference devices have similar set times, too.
- Therefore, the subject device remains substantially equivalent to its predicate device. o
Applicable Standards
- ISO 7405:2018 Dentistry Evaluation of Biocompatibility of Medical Devices Used in Dentistry ●
- ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing ● within a Risk Management Process
- ISO 10993-5:2009 - Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- ISO 14971:2019 Application of Risk Management to Medical Devices ●
- ISO 15233-1:2021 Symbols to be used with Information to be Supplied by the Manufacturer -● Part 1: General Requirements
- ISO 11014:2009 Safety Data Sheet for Chemical Products ●
- ISO 20417:2021 Information to be Supplied by the Manufacturer ●
- ISO 6876:2001 Dental Root Canal Sealing Materials ●
7. Non-Clinical Performance Testing and Compliance
The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of Vista BC Putty to MTA 2.3 (Design 2):
- ISO 6876 Testing ●
- o Benchtop testing on Vista BC Putty was completed following ISO 6876 test protocols for set time, film thickness, solubility and disintegration, and radiopacity. Vista BC Putty was compared to the predicate device (MTA 2.3 (Design 2)) and reference device
10
Image /page/10/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath. To the right of the word is a blue globe, and to the right of the globe is the word "INC." in black.
Image /page/10/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a small "TM" symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller, darker font.
#1 (iRoot FS). Testing confirmed the substantial equivalence of the subject device to the predicate device.
- Shelf-Life Testing
- O Through accelerated shelf-life testing, Vista BC Putty was found to have a shelf-life of two years. Real time aging is being performed on Vista BC Putty to support shelf life during typical storage conditions.
- Transit Testing ●
- o This test confirms that the packaging configurations are sufficient and withstand simulated transit conditions. Moreover, the products performed satisfactory post-transit, which confirms that transit did not have a negative effect on the products themselves.
- Microbiological Testing ●
- Contamination risks from manufacturing are mitigated as Vista BC Putty exhibits o antimicrobial properties. Furthermore, these results help to support shelf stability and multiple use of non-patient contacting materials, such as the svringes, as any introduced microbes will not remain viable within the medical device.
- Cytotoxicity Testing ●
- Vista BC Putty was found to yield better cytotoxicity results compared to the reference O device, Vista BC Sealer.
Clinical Performance Testing and Compliance 8.
Clinical performance is not deemed necessary.
Conclusion 9.
Vista BC Putty is to be marketed by Inter-Med, Inc., 2200 South St., Racine, WI 53404, and is substantially equivalent to MTA 2.3 (Design 2) (K181917). The subject medical device has identical intended use and technological characteristics as the predicate device. Any differences between the subject medical device and predicate medical device do not sigmificantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, Inter-Med concludes that Vista BC Putty is substantially equivalent to the predicate device. MTA 2.3 (Design 2), and the product is safe and effective for its intended use.