Product Code: EGG FDA class 1 21 CFR 872.3165

Attachment, Precision, All

Dental

The Precision Attachment is a dental prosthetic device consisting of interlocking male and female components used to connect removable partial dentures or overdentures to abutment teeth or implants with a precise, retentive fit, providing improved stability compared to conventional clasps. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EGG and the applicable regulation is 21 CFR 872.3165, under the Dental medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: EGG
Device Class: FDA class 1
Regulation Number: 872.3165
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K990979	STECO-TITANMAGNETICS	Sep 03, 1999	Substantially Equivalent	Steco-System-Technik GmbH & Cokg
K950259	COUPLING DEVICE FOR DENTAL PROSTHESIS	Dec 06, 1996	Substantially Equivalent	Dr. Joseph E. Grasso, D.D.S.
K925700	ZEST ANCHOR ADVANCED GENERATION	Apr 07, 1994	Substantially Equivalent	Zest Anchors, Inc.
K915299	COGAN CORP KITS OF DENTAL HAND INSTRUMENTS	Jan 31, 1992	Substantially Equivalent	Cogan Corp.
K912435	DENTAL CONNECTOR PRECISION ATTACHMENT	Aug 28, 1991	Substantially Equivalent	Metalor Dental USA Corp.
K912567	CONICAST, INTRACAST, OMECAST	Jul 02, 1991	Substantially Equivalent	Metalor Dental USA Corp.
K901928	INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH	Jul 26, 1990	Substantially Equivalent	Interpore Intl.
K900785	MICRO 2 SYSTEM	Apr 16, 1990	Substantially Equivalent	Inodent
K896337	DENTAL BRIDGE ANCHORING PINS	Jan 31, 1990	Substantially Equivalent	Gayso Bridge-Tech, Inc.
K895986	PRECISION DENTAL ATTACHMENTS	Oct 18, 1989	Substantially Equivalent	Implant Support Systems, Inc.
K891119	T.R.S.: TOOTH REPLACEMENT SYSTEM	Apr 17, 1989	Substantially Equivalent	Health Technology of America, Inc.
K882063	MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER	Jun 13, 1988	Substantially Equivalent	Zest Anchors, Inc.
K871439	COSMETIC SINGLE SPAN BRIDGE	Jun 08, 1987	Substantially Equivalent	Cosmetic Dental Technologies, Inc.
K870331	IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS	Mar 02, 1987	Substantially Equivalent	Interpore Intl.
K863243	SHINER STRESS DIRECTING ATTACHMENT	Oct 30, 1986	Substantially Equivalent	Js & R - R & D Co.
K861561	ZEST MARK II (STANDARD & MINI)	May 21, 1986	Substantially Equivalent	Zest Anchors, Inc.
K855167	DYNA SYSTEM	Mar 04, 1986	Substantially Equivalent	Parker Laboratories, Inc.
K854633	JACKSON RARE EARTH MAGNETIC ATTACHMENT	Jan 30, 1986	Substantially Equivalent	Solid State Innovations, Inc.
K840600	MAGNE-DENT	Apr 30, 1984	Substantially Equivalent	Magne-Dent
K830439	DENTA A-33	May 09, 1983	Substantially Equivalent	Denta, Inc.
K823280	DISTAFLEX	Nov 22, 1982	Substantially Equivalent	Duradent Corp.
K812360	PRECIOUS-METAL/PLASTIC ATTACH., AUXILL	Sep 21, 1981	Substantially Equivalent	Zl-Microdent-Attachments
K791788	MICRO-RING SYSTEM PRECISION ATTACH.	Oct 22, 1979	Substantially Equivalent	Howmedica Corp.
K780711	MICRO-RING	May 26, 1978	Substantially Equivalent	Howmedica Corp.