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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 26 of 42

Device	Model / Reference	Registries	Class	Status
Restore	41001K	FDA UDI	Class II	Active
Prima	45078K	FDA UDI	Class II	Active
Oct	ITS-PA-NE	FDA UDI	Class II	Unknown
Restore	L1300-34-42K	FDA UDI	Class I	Active
Restore	R9202-40-48K	FDA UDI	Class II	Active
Prima	45048K	FDA UDI	Class II	Active
Prima Plus	15755K	FDA UDI	Class I	Active
Restore	L2301-42-00K	FDA UDI	Class II	Active
Tri-Nex	HA-L-43-3	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA31002	FDA UDI	Class I	Active
Oct	TT6-1	FDA UDI	Class II	Unknown
Renova Implant System	13007K	FDA UDI	Class II	Unknown
Genesis	G71234	FDA UDI	Class II	Active
Oct	TT1	FDA UDI	Class II	Unknown
Prima Implant System	15613K	FDA UDI	Class II	Active
Stage-1	S1500-33-10K	FDA UDI	Class I	Active
Ex Hex Implant System	BAT 18	FDA UDI	Class II	Unknown
Prima	45253K	FDA UDI	Class II	Active
ExHex	GSS9	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA22012	FDA UDI	Class II	Active
Genesis ACTIVE	GA71582	FDA UDI	Class II	Active
Restore	R9201-40-48K	FDA UDI	Class II	Active
Prima	15731K	FDA UDI	Class II	Active
Prima	15650K	FDA UDI	Class I	Active
Restore	ISS1117K	FDA UDI	Class I	Active
Genesis	G21113	FDA UDI	Class II	Active
Tri-Nex Implant System	IA-LH-35-10	FDA UDI	Class II	Unknown
Prima	ISS1112K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71062	FDA UDI	Class II	Active
Restore	L2802-01K	FDA UDI	Class I	Active
Restore	R9291-40-02K	FDA UDI	Class II	Active
Restore	L2700-50-00K	FDA UDI	Class II	Active
ExHex	DN3.5	FDA UDI	Class II	Unknown
Genesis	G71207	FDA UDI	Class II	Active
Restore	L1409-50K	FDA UDI	Class I	Active
Prima	15663K	FDA UDI	Class I	Active
Genesis ACTIVE	GA21006	FDA UDI	Class II	Active
Stage 1	S1800-00K	FDA UDI	Class II	Active
Tri-Nex	HA-L-43W-3	FDA UDI	Class II	Unknown
Stage 1	S1800-15K	FDA UDI	Class II	Active
Genesis	G71451	FDA UDI	Class II	Active
Oct	SYN615D-F6	FDA UDI	Class II	Unknown
Genesis	G21293	FDA UDI	Class I	Active
Genesis ACTIVE	GA71068	FDA UDI	Class II	Active
Prima Implant System	15711K	FDA UDI	Class II	Active
Prima	45280K	FDA UDI	Class II	Active
Prima	45113K	FDA UDI	Class II	Active
Prima	15673K	FDA UDI	Class I	Active
Prima Implant System	15437K	FDA UDI	Class II	Active
Prima Plus	15753K	FDA UDI	Class I	Active

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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