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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 1 of 42

Device	Model / Reference	Registries	Class	Status
Prima	15732K	FDA UDI	Class II	Active
Genesis	G31023	FDA UDI	Class I	Active
Genesis ACTIVE	GA71614	FDA UDI	Class II	Active
Genesis ACTIVE	GA71071	FDA UDI	Class II	Active
Prima	45936K	FDA UDI	Class II	Active
Z-Max	HA-Z-MAX8-3	FDA UDI	Class II	Unknown
Prima	45287K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71630	FDA UDI	Class II	Active
Restore	R9212-40K	FDA UDI	Class II	Active
Restore	R9290-34-04K	FDA UDI	Class II	Active
Restore	42022K	FDA UDI	Class II	Active
Prima	45937K	FDA UDI	Class II	Active
Restore	L9106-1K	FDA UDI	Class I	Active
Prima	15241K	FDA UDI	Class I	Active
Genesis	G71517	FDA UDI	Class II	Active
Z-Max	HA-Z-MAX8-6	FDA UDI	Class II	Unknown
Genesis	G71534	FDA UDI	Class II	Active
Restore	L1504-50-13K	FDA UDI	Class I	Active
Genesis	G71139	FDA UDI	Class II	Active
Restore	L2800-03K	FDA UDI	Class I	Active
Prima	15210K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71048	FDA UDI	Class II	Active
Genesis	G31025	FDA UDI	Class I	Active
Prima	45259K	FDA UDI	Class II	Active
Max	15871K	FDA UDI	Class II	Active
Restore	L1101-28-20K	FDA UDI	Class I	Active
Restore Implant System	TS3810-UK	FDA UDI	Class II	Active
ExHex	HMC4	FDA UDI	Class II	Unknown
Ex Hex Implant System	BBBT 11.5	FDA UDI	Class II	Unknown
Prima	15270K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71043	FDA UDI	Class II	Active
Restore Implant System	RS5011-UK	FDA UDI	Class II	Active
Ex Hex Implant System	IBT 12D-18	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71034	FDA UDI	Class II	Active
Tri-Nex	HA-L-35-3	FDA UDI	Class II	Unknown
Oct Implant System	ITT512	FDA UDI	Class II	Unknown
Restore Implant System	TS4015-UK	FDA UDI	Class II	Active
ExHex	TBA3	FDA UDI	Class II	Unknown
Tri-Nex Implant System	IA50-12D-13	FDA UDI	Class II	Unknown
Restore Implant System	TS5011K	FDA UDI	Class II	Active
Restore Implant System	TS3310K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71584	FDA UDI	Class II	Active
Restore	L2808-01K	FDA UDI	Class I	Active
ExHex	TSUZ9	FDA UDI	Class II	Unknown
Restore	L2308-40-04K	FDA UDI	Class II	Active
Restore	R9660-40-08K	FDA UDI	Class II	Active
Prima	15223K	FDA UDI	Class II	Active
Restore	R9212-55-48K	FDA UDI	Class II	Active
Oct Implant System	ITC312	FDA UDI	Class II	Unknown
Restore	R9305-40-48K	FDA UDI	Class II	Active

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Importers

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Notified Bodies

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Authorities

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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