FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K012303

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Device Name

JEL-20

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2001-08-22

(33 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.

Device Description

Jel-20 is a white Type III Crown & Bridge alloy.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental alloy, stating its substantial equivalence to a predicate device. It does not include a scientific study report or clinical trial results. Therefore, I cannot fulfill your request based on this input.

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K Number

K002993

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Device Name

HERACERAM

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-11-16

(52 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K002645

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Device Name

JEL BIOS PURE

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-10-19

(56 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K031010

Intended Use

Device Description

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K Number

K002222

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Device Name

RD-2104

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-08-31

(38 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K101411

Intended Use

Device Description

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K Number

K001360

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Device Name

SIGNUM

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-06-20

(53 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K001260

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Device Name

ALLROUND 55 LF

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-05-17

(28 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K001196

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Device Name

JEL BIOS 90 (CODE NAME RD-2401)

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-05-11

(29 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K023198

Intended Use

Device Description

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K Number

K000532

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Device Name

JEL 15

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

2000-04-06

(49 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K000213

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Device Name

JELDENT BASIC LINE

Manufacturer

J.F. JELENKO & CO.

Date Cleared

2000-04-06

(73 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K033628

Intended Use

Device Description

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K Number

K993136

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Device Name

JEL BIOS 10 (CODE NAME RD-1801)

Manufacturer

J.F. JELENKO & CO., INC.

Date Cleared

1999-10-21

(31 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.

Device Description

High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.

AI/ML Overview

I am sorry, but since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy, it does not contain information about the acceptance criteria and study details for a device's performance as would be found in a clinical study report. The letter confirms substantial equivalence to a predicate device but does not include the specifics of performance testing.

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