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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 27 of 42

Device	Model / Reference	Registries	Class	Status
ExHex	SB-17-TT	FDA UDI	Class II	Unknown
Renova	10038K	FDA UDI	Class II	Unknown
Prima	45257K	FDA UDI	Class II	Active
Tri-Nex Implant System	TRI-MAX8-11	FDA UDI	Class II	Unknown
Restore Implant System	11004K	FDA UDI	Class II	Active
Renova Implant System	14002K	FDA UDI	Class II	Unknown
Prima	45122K	FDA UDI	Class II	Active
Prima	45424K	FDA UDI	Class II	Active
Genesis	G31001	FDA UDI	Class I	Active
Prima	15744K	FDA UDI	Class II	Active
Genesis	G31018	FDA UDI	Class I	Active
Oct Implant System	MAXIT9-9	FDA UDI	Class II	Unknown
Genesis	G21108	FDA UDI	Class II	Active
Genesis	G31030	FDA UDI	Class I	Active
Max	45341K	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4812-2K	FDA UDI	Class II	Active
Prima	15742K	FDA UDI	Class II	Active
Restore Implant System	RS4011K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71580	FDA UDI	Class II	Active
Genesis ACTIVE	GA71536	FDA UDI	Class II	Active
Genesis	G31011	FDA UDI	Class I	Active
Genesis	G71435	FDA UDI	Class II	Active
Prima	15072K	FDA UDI	Class I	Active
Prima	15071K	FDA UDI	Class I	Active
Oct Implant System	MAXIT9-11	FDA UDI	Class II	Unknown
Ex Hex Implant System	BA 10	FDA UDI	Class II	Unknown
Prima Implant System	15436K	FDA UDI	Class II	Active
Renova	10036K	FDA UDI	Class II	Unknown
Restore	ISS1109K	FDA UDI	Class I	Active
Oct Implant System	ITC506	FDA UDI	Class II	Unknown
Genesis	G71208	FDA UDI	Class II	Active
Renova	43103K	FDA UDI	Class II	Unknown
Prima Implant System	15401K	FDA UDI	Class II	Active
Prima	15681K	FDA UDI	Class II	Active
Prima	15658K	FDA UDI	Class I	Active
Prima	15275K	FDA UDI	Class I	Active
Prima	45326K	FDA UDI	Class II	Active
Stage 1	42000K	FDA UDI	Class II	Active
Stage-1	S1100-20-10K	FDA UDI	Class I	Active
Genesis Implant System	G21050	FDA UDI	Class II	Unknown
Prima	45264K	FDA UDI	Class II	Active
Restore Implant System	RS5010K	FDA UDI	Class II	Active
Prima Implant System	15622K	FDA UDI	Class II	Active
Prima	45123K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71624	FDA UDI	Class I	Active
Genesis ACTIVE	GA71603	FDA UDI	Class I	Active
Restore	R9650-40-06K	FDA UDI	Class II	Active
Genesis	G71532	FDA UDI	Class II	Active
Genesis ACTIVE	GA71051	FDA UDI	Class II	Active
Genesis	G71147	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