Who is the manufacturer of NEO 76?

Sb Lucius, Inc. filed the 510(k) submission for NEO 76 (K024141).

What is the FDA product code for NEO 76?

EJT. It is classified under 21 CFR 872.3060 as a Class 2 device in the Dental panel.

What is the regulatory pathway for NEO 76?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NEO 76?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEO 76

K024141 · Sb Lucius, Inc. · EJT · Mar 6, 2003 · Dental

Device Facts

Record ID	K024141
Device Name	NEO 76
Applicant	Sb Lucius, Inc.
Product Code	EJT · Dental
Decision Date	Mar 6, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3060
Device Class	Class 2
Attributes	Therapeutic

Intended Use

NEO 76 is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials -

Device Story

NEO 76 is a 76% gold-based dental casting alloy used by dental technicians to fabricate dental restorations. The device is processed via standard dental casting techniques to create inlays, onlays, crowns, and bridges. The resulting metallic restoration is placed by a dentist to restore tooth structure or replace missing teeth. The alloy provides a high-gold appearance and mechanical properties suitable for both short and long-span bridge applications. It serves as a restorative material to improve patient oral function and aesthetics.

Clinical Evidence

Bench testing only. Physical and mechanical properties (melting point, hardness, yield strength, elongation, density) were compared against the predicate device using ANSI/ADA 5 and ISO 9693 test methods.

Technological Characteristics

Gold-based dental casting alloy (76% gold). Physical properties: Melting range 1,784-1,840°F, Vickers hardness 148, yield strength 270 MPa, elongation 48%, density 16.1 g/cm3. Tested per ANSI/ADA 5 and ISO 9693 standards.

Indications for Use

Indicated for use in the fabrication of dental restorations including inlays, onlays, crowns, short-span bridges, long-span bridges, and removable partials.

Regulatory Classification

Identification

A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

Predicate Devices

ARGENCO 77 (K893385)

Related Devices

K023200 — CERANUM 76 · Sb Lucius, Inc. · Nov 4, 2002
K023196 — LUCIUS 76 · Sb Lucius, Inc. · Nov 1, 2002
K024139 — AIGIS-INLAY · Sb Lucius, Inc. · Mar 7, 2003
K024144 — AIGIS-PT · Sb Lucius, Inc. · Mar 7, 2003
K024140 — AIGIS-A · Sb Lucius, Inc. · Mar 6, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ K 024141 MAR 0 6 2003 ### 510(K) SUMMARY Submitter of 510(k): SB LUCIUS, INC. 9778 Katella Ave. Ste. 205, Anaheim, CA 92804 Phone: (714) 530-2814, Fax : (714) 530-3448, | Contact person: | Dae Kyu Chang | |-----------------|---------------------| | Phone: | (714) 530-2814 | | Fax: | (714) 530-3448 | | E-mail: | Gatorkr@yahoo.co.kr | Date of Summary: Dec 15, 2002 | Trade name: | NEO 76 | |----------------------|-----------------------------------------------------------------| | Common: | Dental casting alloy | | Classification name: | Gold based alloys and precious metal alloys for clinical use | | Product code: | EJT | | Classification: | Class II | l.egally marketed device: ARGENCO 77 !510(k) number: K893385 ### SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Test methods applied: as in ANSI/ADA 5 and ISO 9693 #### Comparison of composition: | THE SECTION FOR POST OF COLLECTION STATES OF THE FORM THE | | | C ﻠ . " " - " C 17 11 A the procession and any and the problems of the | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name GVICE a su submit se parties a se non and sense and comment of the proposes on a superformation of the senses | 1 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Party I a m a d it of a conventual div Broader | 1 | a para simple para compension and le since supers and se surveys and service in als la minded de la program and lesses and sense | | 1 . Property 【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】 | . | | ﻟ 1 ( -1 -- 1 ) | PPS 4049 | | | | 1 1 1 1 | | | | 【日】【:】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】】【】】【】【】】【】【】】【】】【】【】】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ E ﮔ t 11 . 1 . 1 . 1 . 1 | and actively productions ward + 1.0 Kin bolish 1 | 2 Ana | Company of Call Clark Control Concession Children Company College Company Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come [ 0 | . 1 | A P P P S P . E S P S P S P S P S . C . L . L . L . L . L . L | A WHERE . EN'S S LA S E E S T C S S T C S S T C S MINNERS MALES LINE PRESENT LAND A LA LA MARK LA MARK LA MEL LE MEL LE MEL LE MEL SE LE MEL SE LE MEL SE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE L | 11 1 1 7 8 1 8 8 8 8 8 8 8 3 8 3 5 3 5 5 5 5 5 5 5 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 3 3 3 3 3 3 3 3 3 3 3 3 | ## POSITION WEIGHT W Comparison of physical and mechanical properties: | Alloy | Melting Point Range (°F) | Hardness (Vickers) | Yield Strength (MPa) | Elongation (%) | Density (g/cm3) | |------------|--------------------------|--------------------|----------------------|----------------|-----------------| | ARGENCO 77 | 1,695 - 1,760 | 105 | 214 | 36 | 15.9 | | NEO 76 | 1,784-1,840 | 148 | 270 | 48 | 16.1 | {1}------------------------------------------------ #### Discussion: Since the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar. #### Conclusion: The main elements and their concentration are almost identical. NEO 76 is arı inlay, onlay, crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. NEO 76 is excellent for inlays, threequarter crowns, long and short-span bridges. NEO 76 is substantially equivalent to ARGENCO 77 and the minor differences between them do not affect safety or effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. MAR 0 6 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Dae-Kyu Chang SB LUCIUS, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804 Re: K024141 Trade/Device Name: NEO 76 Regulation Number: 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: December 15, 2003 Received: December 16, 2003 Dear Mr. Chang We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ Page 2 - Mr. Chang 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Rumer Susan Runner, DDS. MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ SB LUCIUS,INC. 9778 Katella Ave. Ste. 205, Anaheim, CA 92804 Phone: (714) 530-2814, Fax : (714) 530-3448, # INDICATIONS FOR USE 510(K) Number: KC24141 # Device Name(s) : NEO 76 NEO 76 is intended for manufacturing - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials - (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED) Suan Ruse. ision Sign-Off ivision of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: