ASD Oral Appliances

• K Number: K163580
• Device Name: ASD Oral Appliances
• Manufacturer: AMERICAN SLEEP DENTISTRY
• Date Cleared: 2017-06-08 ( 170 days)
• Product Code: LRK
• Regulation Number: 872.5570

Intended Use

The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Device Description

The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy. The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.

Predicate Devices

K130504

Reference Devices

K070327, K062951, K971794

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical, mechanical oral appliance and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is intended for the "reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)", which are therapeutic purposes.

Diagnostic

No

The device is intended for the reduction of snoring and sleep apnea symptoms, not for the diagnosis of these conditions. It is a treatment device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states that the devices are "removable, intraoral devices" comprised of "thermoformed polymer splints" and "hook and base mechanism or elastic bands or straps," indicating a physical hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The ASD Oral Appliances are physical devices that are placed inside the mouth to reposition the jaw. They do not analyze biological samples.
• Intended Use: The intended use is for the reduction of snoring and sleep apnea, which is a physical intervention, not a diagnostic test.

The device description and intended use clearly indicate a physical, intraoral appliance for therapeutic purposes, not a diagnostic test performed on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Product codes (comma separated list FDA assigned to the subject device)

LRK

Device Description

The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.

The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intraoral (jaw, throat)

Indicated Patient Age Range

18 years of age or older

Intended User / Care Setting

Fitted by a clinician, used at home.

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)

Not Found

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.

K130504

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.

K070327, K062951, K971794

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

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or head in profile, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 8, 2017

American Sleep Dentistry Ryan Gregerson President 1957 West Royal Hunte Drive Ste 250 Cedar City, Utah 84720-1903

Re: K163580

Trade/Device Name: ASD Oral Appliances Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: May 5, 2017 Received: May 9, 2017

Dear Ryan Gregerson:

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.

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

1

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -A

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163580

Device Name

American Sleep Dentistry (ASD) Oral Appliances

Indications for Use (Describe)

The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K163580 510(k) Summary

Date:	May 31, 2017
Sponsor:	American Sleep Dentistry, LLC
1957 West Royal Hunte Dr, Ste 250
Cedar City, UT 84720-1903
Phone: [phone]
Contact Person:	Ryan Gregerson, Manager
Trade Names:	American Sleep Dentistry (ASD) Oral Appliances
Device Classification:	Class II
Classification Name:	Device, Anti-Snoring and device, jaw repositioning
Regulation:	21 CFR 872.5570, Intraoral devices for snoring and
intraoral devices for snoring and obstructive sleep apnea
Device Product Code:	LRK

Device Description: The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.

The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.

Intended Use: The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in individuals 18 years of age or older.

Primary Predicate Device:

American Sleep Association (ASA) Oral Appliances (K130504)

Reference Predicate Devices:

Removable Acrylic Herbst (K070327) TAP III (K062951) EMA (K971794)

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Technological Characteristics:

The ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances possess the same technological characteristics as one or more of the predicate devices.

These include:

• . Anatomic location (intraoral),
• Intended Use, to treat mild to moderate sleep apnea.
• Basic design (mandibular repositioning using upper and lower polymer trays with a . hook and base mechanism),
• . Principles of Operation
• . Materials (polymer and/or stainless steel), and
• Manufacture (appliance is patient specific fabricated by prescription to the specific ● requirements of a single patient).

The ASD Anterior model and predicate device, Tap III are both patient specific made Oral Appliances that include a hook and base mechanism placed on the anterior of the front teeth. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Lateral model and predicate device Tap III are both patient specific made Oral Appliances that include a hook and base mechanism and is located the same as the TAP III, but the ASD Lateral model adds the additional anchors to the canine teeth for advanced stability. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Lateral Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism. The ASD Lateral Mezzo hook and base mechanism is like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differ slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Elastic model and predicate device EMA are both patient specific made Oral Appliances that include varying lengths of elastic bands or straps and are both placed bilaterally. The ASD Elastic, however anchors the straps in by stainless steel, while the EMA uses plastic anchors. The actual material differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The fundamental scientific technology of the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances is the same as previously cleared devices.

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| Substantial
Equivalence
Comparison
Features | ASD
Anterior,
ASD Mezzo,
ASD Lateral,
ASD Elastic
and ASD
Lateral
Mezzo | ASA Oral
Appliances
[Primary
Predicate] | Removable
Acrylic
Herbst
[Reference
Predicate] | Tap III
[Reference
Predicate] | EMA
[Reference
Predicate] |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Intended
use/
Indications
for use: | Intended for
the reduction
of nighttime
snoring and
mild to
moderate
obstructive
sleep apnea
(OSA) in
individuals 18
years of age
or older. | Intended for
the reduction
of nighttime
snoring and
mild to
moderate
obstructive
sleep apnea
(OSA) in
individuals 18
years of age
or older. | Intended for
the reduction
of snoring
and mild to
moderate
obstructive
sleep apnea
(OSA) by
moving the
lower jaw into
a prescribed
relationship
to the upper
jaw. | Intended to
reduce or
alleviate
nighttime
snoring and
mild to
moderate
obstructive
sleep apnea,
OSA. | Treatment of
nasal
respiratory
dysfunction of
obstructive
sleep apnea
and snoring
in those
patients
where
repositioning
of the
mandible can
increase the
patient's air
space |
| Prescription/
OTC Use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Principle of
Operation | Once fitted
to the patient,
the device
positions the
lower jaw
forward,
preventing
soft tissue of
the throat
from
collapsing
and
obstructing
the airway,
therefore
alleviating or
reducing the
symptoms of
nighttime
snoring and
mild to
moderate | Once fitted to
the patient,
the device
positions the
lower jaw
forward,
preventing
soft tissue of
the throat
from
collapsing
and
obstructing
the airway,
therefore
alleviating or
reducing the
symptoms of
nighttime
snoring and
mild to
moderate | Once fitted to
the patient,
the device
positions the
lower jaw
forward,
preventing
soft tissue of
the throat
from
collapsing
and
obstructing
the airway,
therefore
alleviating or
reducing the
symptoms of
nighttime
snoring and
mild to
moderate | Once fitted to
the patient,
the device
positions the
lower jaw
forward,
preventing
soft tissue of
the throat
from
collapsing
and
obstructing
the airway,
therefore
alleviating or
reducing the
symptoms of
nighttime
snoring and
mild to
moderate | Once fitted to
the patient,
the device
positions the
lower jaw
forward,
preventing
soft tissue of
the throat
from
collapsing
and
obstructing
the airway,
therefore
alleviating or
reducing the
symptoms of
nighttime
snoring and
mild to
moderate |
| American Sleep Dentistry, LLC
ASD Oral Appliances
Traditional Premarket Notification [510(k)]
May 2017 | | | | | |
| Substantial
Equivalence
Comparison
Features | ASD
Anterior,
ASD Mezzo,
ASD Lateral,
ASD Elastic
and ASD
Lateral
Mezzo | ASA Oral
Appliances
[Primary
Predicate] | Removable
Acrylic
Herbst
[Reference
Predicate] | Tap III
[Reference
Predicate] | EMA
[Reference
Predicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| | Obstructive
Sleep Apnea
(OSA). | Obstructive
Sleep Apnea
(OSA). | Obstructive
Sleep Apnea
(OSA). | Obstructive
Sleep Apnea
(OSA). | Obstructive
Sleep Apnea
(OSA). |
| Design:
ASD
Anterior | Mandibular
repositioner
having upper
and lower
polymer trays
with hook and
base
mechanism
placed on the
anterior of the
front teeth. | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms
with bilateral,
reclosable,
polymer
fasteners or
both | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms | Mandibular
repositioner
having upper
and lower
trays with a
Hook and
Base
mechanism
placed on the
anterior of the
front teeth. | |
| Design:
ASD Mezzo | Mandibular
repositioner
having upper
and lower
polymer trays
with a hook
and base
mechanism
placed
bilaterally | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms
with bilateral,
reclosable,
polymer
fasteners or
both | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms | Mandibular
repositioner
having upper
and lower
trays with a
Hook and
Base
mechanism
placed on the
anterior of the
front teeth. | |
| American Sleep Dentistry, LLC | | | Traditional Premarket Notification [510(k)] | | |
| ASD Oral Appliances | | | May 2017 | | |
| Substantial
Equivalence
Comparison
Features | ASD
Anterior,
ASD Mezzo,
ASD Lateral,
ASD Elastic
and ASD
Lateral
Mezzo | ASA Oral
Appliances
[Primary
Predicate] | Removable
Acrylic
Herbst
[Reference
Predicate] | Tap III
[Reference
Predicate] | EMA
[Reference
Predicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Design:
ASD Lateral | Mandibular
repositioner
having upper
and lower
polymer trays
with hook and
base
mechanism
placed on the
anterior of the
teeth. With
anchors
placed on the
canine teeth. | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms
with bilateral,
reclosable,
polymer
fasteners or
both | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms | Mandibular
repositioner
having upper
and lower
trays with a
Hook and
Base
mechanism
placed on the
anterior of the
front teeth. | |
| Design:
ASD Lateral
Mezzo | Mandibular
repositioner
having upper
and lower
polymer trays
with a hook
and base
mechanism
placed
bilaterally | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms
with bilateral,
reclosable,
polymer
fasteners or
both | Mandibular
repositioner
having upper
and lower
polymer trays
with bilateral
Herbst
mechanisms | Mandibular
repositioner
having upper
and lower
trays with a
Hook and
Base
mechanism
placed on the
anterior of the
front teeth. | |
| | | | | | |
| ASD Oral Appliances
May 2017 | | | | | |
| Substantial
Equivalence
Comparison
Features | ASD
Anterior,
ASD Mezzo,
ASD Lateral,
ASD Elastic
and ASD
Lateral
Mezzo | ASA Oral
Appliances
[Primary
Predicate] | Removable
Acrylic
Herbst
[Reference
Predicate] | Tap III
[Reference
Predicate] | EMA
[Reference
Predicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Design:
ASD Elastic | Mandibular
repositioner
having upper
and lower
polymer trays
and elastic
bands or
straps with
stainless
steel
anchors. | | | | Mandibular
repositioner
having upper
and lower
trays with
bilateral
elastic bands
or straps with
plastic
anchors. |
| Materials:
ASD
Anterior
ASD Mezzo
ASD Lateral
ASD Lateral
Mezzo | | | | | |
| Polymer
Splint | | PETG/TPU,
EVA | Acrylic | Acrylic | |
| Connecting
Mechanism | | 303/304
Stainless
Steel | 303/304
Stainless
Steel | 303/304
Stainless
Steel | |
| Materials:
ASD Elastic | | | | | |
| Polymer
Splint | PETG/TPU,
EVA | | | | Acrylic |
| Connecting
Mechanism | Latex free
Polymer | | | | Latex free
Polymer |
| eep Dentistry, LLC | | Traditional Premarket Notification [510(k)] | | | |
| Opliances | | | | May 2017 | |
| ASD
Anterior,
ASD Mezzo,
ASD Lateral,
ASD Elastic
and ASD
Lateral
Mezzo | ASA Oral
Appliances
[Primary
Predicate] | Removable
Acrylic
Herbst
[Reference
Predicate] | Tap III
[Reference
Predicate] | EMA
[Reference
Predicate] | |
| K163580 | K130504 | K070327 | K062951 | K971794 | |
| | | | | | |
| Front to back
+/- 1 mm | Front to back
+/- 1 mm | Front to back
+/- 1 mm | Front to back
+/- 1 mm | Front to back
+/- 1 mm | |
| Patients
diagnosed
with mild to
moderate
Obstructive | Patients
diagnosed
with mild to
moderate
Obstructive | Patients
diagnosed
with mild to
moderate
Obstructive | Patients
diagnosed
with mild to
moderate
Obstructive | Patients
diagnosed
with mild to
moderate
Obstructive | |

B. Substantial Equivalence Comparison Table:

6

7

Traditional Premarket Notification [510(k)]

8

Traditional Premarket Notification [510(k)]

9

American Sleep ASD Oral Applia

Substantial

Equivalence
Comparison
Features

510k #

| Range and
precision of
adjustment | Front to back
+/- 1 mm | Front to back
+/- 1 mm | Front to back
+/- 1 mm | Front to back
+/- 1 mm | Front to back
+/- 1 mm |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target
Population | Patients
diagnosed
with mild to
moderate
Obstructive
Sleep Apnea | Patients
diagnosed
with mild to
moderate
Obstructive
Sleep Apnea | Patients
diagnosed
with mild to
moderate
Obstructive
Sleep Apnea | Patients
diagnosed
with mild to
moderate
Obstructive
Sleep Apnea | Patients
diagnosed
with mild to
moderate
Obstructive
Sleep Apnea |
| Where Used: | Fitted by a
clinician,
used at
home. | Fitted by a
clinician,
used at
home. | Fitted by a
clinician,
used at
home. | Fitted by a
clinician,
used at
home. | Fitted by a
clinician,
used at
home. |
| Energy
Used/
Delivered: | None | None | None | None | None |
| Human
Factors: | The device is
fitted by the
dentist. The
patient is
instructed in
its use and
care.
Subsequent
use by the
patient is as
directed by
the dentist in
accordance
with the
provided
instructions
for use. | The device is
fitted by the
dentist. The
patient is
instructed in
its use and
care.
Subsequent
use by the
patient is as
directed by
the dentist in
accordance
with the
provided
instructions
for use. | The device is
fitted by the
dentist. The
patient is
instructed in
its use and
care.
Subsequent
use by the
patient is as
directed by
the dentist in
accordance
with the
provided
instructions
for use. | The device is
fitted by the
dentist. The
patient is
instructed in
its use and
care.
Subsequent
use by the
patient is as
directed by
the dentist in
accordance
with the
provided
instructions
for use. | The device is
fitted by the
dentist. The
patient is
instructed in
its use and
care.
Subsequent
use by the
patient is as
directed by
the dentist in
accordance
with the
provided
instructions
for use. |
| | | | | | |

10

Traditional Premarket Notification [510(k)]

ASD Oral Appliances					May 2017
Substantial
Equivalence
Comparison
Features	ASD
Anterior,
ASD Mezzo,
ASD Lateral,
ASD Elastic
and ASD
Lateral
Mezzo	ASA Oral
Appliances
[Primary
Predicate]	Removable
Acrylic
Herbst
[Reference
Predicate]	Tap III
[Reference
Predicate]	EMA
[Reference
Predicate]
510k #	K163580	K130504	K070327	K062951	K971794
Sterility:	Non-sterile.
Device is
cleaned
between uses
by the patient
following
instructions
provided by
its
manufacturer	Non-sterile.
Device is
cleaned
between uses
by the patient
following
instructions
provided by
its
manufacturer	Non-sterile.
Device is
cleaned
between uses
by the patient
following
instructions
provided by
its
manufacturer	Non-sterile.
Device is
cleaned
between uses
by the patient
following
instructions
provided by
its
manufacturer	Non-sterile.
Device is
cleaned
between uses
by the patient
following
instructions
provided by
its
manufacturer

Conclusion:

In comparison to the predicate devices, the ASD Oral Appliances have:

• The same intended use, and
• The same technological characteristics and so do not raise new questions of safety . and effectiveness.

Therefore, the proposed ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo Oral Appliances are deemed substantially equivalent to the predicate devices based on a review of the descriptive characteristics of each device model.