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Keystone Dental Inc.

Last updated September 17, 2026

Information

Country: US
Address: 13645 Alton Pkwy Ste A, Irvine, CA, 92618
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011936113
DUNS Number: —

Catalogue (2088)

Page 36 of 42

Device	Model / Reference	Registries	Class	Status
Genesis	G71220	FDA UDI	Class II	Active
Prima	45262K	FDA UDI	Class II	Active
Restore Implant System	RS6008K	FDA UDI	Class II	Active
Genesis	G71538	FDA UDI	Class II	Active
Tri-Nex Implant System	IA50-12D-11.5	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15114	FDA UDI	Class I	Active
Genesis ACTIVE	GA71553	FDA UDI	Class II	Active
Tri-Nex Implant System	IA43-12D-11.5	FDA UDI	Class II	Unknown
ExHex	GC-NX-70	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71067	FDA UDI	Class II	Active
Restore	L2100-35-24K	FDA UDI	Class I	Active
Tri-Nex	PA-EL-60	FDA UDI	Class II	Unknown
Prima	15278K	FDA UDI	Class I	Active
Tri-Nex	MC-L-50-1	FDA UDI	Class II	Unknown
Prima	45324K	FDA UDI	Class II	Active
Prima	15321K	FDA UDI	Class II	Active
Oct	TS-IT-PA	FDA UDI	Class II	Unknown
ExHex	AMCZ4	FDA UDI	Class II	Unknown
Prima	15730K	FDA UDI	Class II	Active
Restore Implant System	RS3313K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71660	FDA UDI	Class I	Active
Prima Implant System	15433K	FDA UDI	Class II	Active
Restore	L1301-20-30K	FDA UDI	Class I	Active
Restore	11026K	FDA UDI	Class I	Active
Genesis	G21104	FDA UDI	Class II	Active
Genesis	G31010	FDA UDI	Class I	Active
Restore	L1104-33-15K	FDA UDI	Class I	Active
Prima	45120K	FDA UDI	Class II	Active
Restore	L1404-38-02K	FDA UDI	Class I	Active
Genesis	G71140	FDA UDI	Class II	Active
Genesis ACTIVE	GA71064	FDA UDI	Class II	Active
Prima Plus	15729K	FDA UDI	Class I	Active
Z-Max	TC-MAX-3	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBS 11.5	FDA UDI	Class II	Unknown
Prima Implant System	15619K	FDA UDI	Class II	Active
Max	45359K	FDA UDI	Class II	Active
Genesis ACTIVE	GA22004	FDA UDI	Class II	Active
Tri-Nex	TCA24-EL-43	FDA UDI	Class II	Unknown
Restore	R9633-34-02K	FDA UDI	Class II	Active
Prima	15685K	FDA UDI	Class I	Active
Prima Plus	15766K	FDA UDI	Class I	Active
Prima Implant System	15617K	FDA UDI	Class II	Active
Prima	15684K	FDA UDI	Class I	Active
Genesis	G71443	FDA UDI	Class II	Active
Prima	15792K	FDA UDI	Class II	Active
Restore	L2100-80-19K	FDA UDI	Class I	Active
Prima	45057K	FDA UDI	Class II	Active
Z-Max	TC-MAX-1	FDA UDI	Class II	Unknown
Restore	L2304-42-04K	FDA UDI	Class II	Active
Renova Implant System	14006K	FDA UDI	Class II	Unknown

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FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 22, 2019	Z-1061-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Feb 22, 2019	Z-1062-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Feb 22, 2019	Z-1063-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Feb 22, 2019	Z-1064-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
May 1, 2018	Z-2162-2018	—	terminated	The implants are mislabeled.
Mar 13, 2018	Z-1485-2018	—	terminated	The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Jan 24, 2018	Z-1443-2018	—	terminated	The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Oct 16, 2017	Z-1179-2018	—	terminated	A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
Aug 25, 2017	Z-0727-2018	—	terminated	The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
Jun 20, 2017	Z-0608-2018	—	terminated	Abutments are unable to accept the final abutment screw
Jun 16, 2017	Z-0718-2018	—	terminated	An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Mar 9, 2017	Z-1818-2017	—	terminated	Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Sep 15, 2016	Z-0299-2017	—	terminated	Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Mar 11, 2013	Z-0973-2013	—	terminated	Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Jul 5, 2011	Z-0923-2013	—	terminated	Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Jul 5, 2011	Z-0924-2013	—	terminated	Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment