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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 14 of 42

Device	Model / Reference	Registries	Class	Status
Restore	R9642-34-06K	FDA UDI	Class II	Active
Genesis	G71135	FDA UDI	Class II	Active
Restore Implant System	TS4010-UK	FDA UDI	Class II	Active
Prima Implant System	15404K	FDA UDI	Class II	Active
Oct	TSIT2	FDA UDI	Class II	Unknown
Renova Implant System	13005K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA22002	FDA UDI	Class II	Active
Genesis ACTIVE	GA71604	FDA UDI	Class I	Active
ExHex	EPC-TN-43-3KT	FDA UDI	Class II	Unknown
ExHex	EPC-TN-35-2KT	FDA UDI	Class II	Unknown
Stage-1	S1803-28K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71050	FDA UDI	Class II	Active
Genesis ACTIVE	GA71628	FDA UDI	Class II	Active
Stage-1	S1100-35-10K	FDA UDI	Class I	Active
Ex Hex Implant System	IBT 8.5	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71601	FDA UDI	Class I	Active
Oct Implant System	ITT510	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71044	FDA UDI	Class II	Active
Tri-Nex Implant System	IA-LH-60-8	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71621	FDA UDI	Class II	Active
Genesis ACTIVE	GA71540	FDA UDI	Class II	Active
Restore Implant System	RS6015K	FDA UDI	Class II	Active
Genesis Implant System	G21144	FDA UDI	Class II	Active
Restore Implant System	RS3811-UK	FDA UDI	Class II	Active
Genesis	G71506	FDA UDI	Class II	Active
Genesis ACTIVE	GA71602	FDA UDI	Class I	Active
Restore	R9660-40-06K	FDA UDI	Class II	Active
Restore	R9633-40-06K	FDA UDI	Class II	Active
Restore	R9086-40-05K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71565	FDA UDI	Class I	Active
Genesis ACTIVE	GA71042	FDA UDI	Class II	Active
Genesis ACTIVE	GA71562	FDA UDI	Class II	Active
Restore	L2308-34-04K	FDA UDI	Class II	Active
Prima Plus	15756K	FDA UDI	Class I	Active
Restore Implant System	RS3813-UK	FDA UDI	Class II	Active
ExHex	ABBBMC30D-4	FDA UDI	Class II	Unknown
Ex Hex Implant System	MAX-8-9	FDA UDI	Class II	Unknown
Restore Implant System	TS3815-UK	FDA UDI	Class II	Active
Prima	45319K	FDA UDI	Class II	Active
Prima	15738K	FDA UDI	Class II	Active
ExHex	SBBB-17-TT	FDA UDI	Class II	Unknown
Renova Implant System	13000K	FDA UDI	Class II	Unknown
Genesis	K15695	FDA UDI	Class I	Active
Prima	15670K	FDA UDI	Class I	Active
Prima	45939K	FDA UDI	Class II	Active
Prima	45938K	FDA UDI	Class II	Active
Tri-Nex	MCL-43-17D2	FDA UDI	Class II	Unknown
Genesis	G71146	FDA UDI	Class II	Active
Prima	15320K	FDA UDI	Class II	Active
Genesis ACTIVE	GA22011	FDA UDI	Class II	Active

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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