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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 32 of 42

Device	Model / Reference	Registries	Class	Status
Genesis ACTIVE	GA71538	FDA UDI	Class II	Active
Restore	L1100-20-10K	FDA UDI	Class I	Active
Prima Plus	15775K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23017	FDA UDI	Class II	Active
Stage-1	S1101-28-16K	FDA UDI	Class I	Active
Genesis ACTIVE	GA21012	FDA UDI	Class II	Active
Genesis ACTIVE	GA22021	FDA UDI	Class II	Active
Restore Implant System	RS3810K	FDA UDI	Class II	Active
Renova	43096K	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15113	FDA UDI	Class I	Active
Genesis ACTIVE	G15115	FDA UDI	Class I	Active
Genesis	G31040	FDA UDI	Class I	Active
Prima	45035K	FDA UDI	Class II	Active
Renova	43113K	FDA UDI	Class II	Unknown
Prima Implant System	15411K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71551	FDA UDI	Class II	Active
ExHex	TCB1NH	FDA UDI	Class II	Unknown
Restore	L1200-40-10K	FDA UDI	Class I	Active
Prima Implant System	15430K	FDA UDI	Class II	Active
Stage 1	S2432-40-1K	FDA UDI	Class II	Active
Stage-1	S2418-13-1K	FDA UDI	Class I	Active
Genesis	G31022	FDA UDI	Class I	Active
Genesis ACTIVE	GA71046	FDA UDI	Class II	Active
Stage 1	42020K	FDA UDI	Class II	Active
Restore	L1805-20-00K	FDA UDI	Class I	Active
ExHex	AMCZ3	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBT 12D-8.5	FDA UDI	Class II	Unknown
Restore	L2505-60-03K	FDA UDI	Class II	Active
Max	45338K	FDA UDI	Class II	Active
Genesis	G71211	FDA UDI	Class II	Active
Restore	L1809-50-01K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71567	FDA UDI	Class I	Active
Stage-1	S2503K	FDA UDI	Class I	Active
Prima	15715K	FDA UDI	Class II	Unknown
Genesis	G31033	FDA UDI	Class I	Active
Oct Implant System	ITT412	FDA UDI	Class II	Unknown
Renova	43119K	FDA UDI	Class II	Unknown
Prima Implant System	15712K	FDA UDI	Class II	Active
Prima	15254K	FDA UDI	Class I	Active
Stage-1	S1101-35-10K	FDA UDI	Class I	Active
Prima Implant System	15413K	FDA UDI	Class II	Active
Sustain	410475-3-20K	FDA UDI	Class II	Active
Genesis ACTIVE	GA21008	FDA UDI	Class II	Active
Prima	15269K	FDA UDI	Class I	Active
Restore Implant System	RS5015K	FDA UDI	Class II	Active
Oct	ITS-PA	FDA UDI	Class II	Unknown
Oct Implant System	ITC512	FDA UDI	Class II	Unknown
Genesis Implant System	G21142	FDA UDI	Class II	Active
Genesis ACTIVE	GA71069	FDA UDI	Class II	Active
Genesis ACTIVE	GA21002	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