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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 12 of 42

Device	Model / Reference	Registries	Class	Status
Restore	L1404-96-20K	FDA UDI	Class I	Active
Stage-1	S9101-2K	FDA UDI	Class I	Active
Restore	L1810-34-01K	FDA UDI	Class II	Active
Renova	43105K	FDA UDI	Class II	Unknown
Restore	L2101-96-16K	FDA UDI	Class I	Active
ExHex	EPC-EX-50-2KT	FDA UDI	Class II	Unknown
Z-Max	SA-Z-MAX-60-3	FDA UDI	Class II	Unknown
Prima Implant System	15402K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71622	FDA UDI	Class II	Active
Genesis	45814K	FDA UDI	Class II	Active
ExHex	ABAMC17D-3	FDA UDI	Class II	Unknown
ExHex	GSUZ3	FDA UDI	Class II	Unknown
Prima	45291K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71061	FDA UDI	Class II	Active
Genesis	G71504	FDA UDI	Class II	Active
Genesis	G21246	FDA UDI	Class I	Active
ExHex	AMC2	FDA UDI	Class II	Unknown
Prima Plus	15750K	FDA UDI	Class I	Active
Genesis	G71218	FDA UDI	Class II	Active
Genesis	G71448	FDA UDI	Class II	Active
Restore	L1813-01K	FDA UDI	Class I	Active
Oct	SYN620D-F6	FDA UDI	Class II	Unknown
Tri-Nex	MC-L-35-3	FDA UDI	Class II	Unknown
ExHex	TCBA1H	FDA UDI	Class II	Unknown
Prima	45281K	FDA UDI	Class II	Active
Tri-Nex	PA-EL-35P	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71615	FDA UDI	Class II	Active
Genesis	G71501	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 18	FDA UDI	Class II	Unknown
Renova	10033K	FDA UDI	Class II	Unknown
Renova Implant System	13001K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA23021	FDA UDI	Class II	Active
Prima	15736K	FDA UDI	Class II	Active
ExHex	ABBBMC3	FDA UDI	Class II	Unknown
Genesis	G21243	FDA UDI	Class I	Active
ExHex	TCBA1NH	FDA UDI	Class II	Unknown
Prima	45047K	FDA UDI	Class II	Active
Tri-Nex	PA-EL-50	FDA UDI	Class II	Unknown
Genesis	G21014	FDA UDI	Class I	Active
Max	45355K	FDA UDI	Class II	Active
Genesis ACTIVE	GA22006	FDA UDI	Class II	Active
Genesis Implant System	G21147	FDA UDI	Class II	Active
Genesis ACTIVE	GA71574	FDA UDI	Class II	Active
PrimaSolo	15229K	FDA UDI	Class I	Active
Prima	15271K	FDA UDI	Class I	Active
Ex Hex Implant System	BAT 24D-11.5	FDA UDI	Class II	Unknown
ExHex	DBAS24	FDA UDI	Class II	Unknown
Prima	45237K	FDA UDI	Class II	Active
Prima	45156K	FDA UDI	Class II	Active
Oct Implant System	ITC508	FDA UDI	Class II	Unknown

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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