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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 30 of 42

Device	Model / Reference	Registries	Class	Status
Tri-Nex Implant System	IA-LH-35-11.5	FDA UDI	Class II	Unknown
Prima	45121K	FDA UDI	Class II	Active
ExHex	EPC-TN-43-1KT	FDA UDI	Class II	Unknown
Restore	R9201-55-48K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71636	FDA UDI	Class II	Active
Renova Implant System	13003K	FDA UDI	Class II	Unknown
Stage 1	S2432-70-1K	FDA UDI	Class II	Active
Genesis	G71515	FDA UDI	Class II	Active
Genesis ACTIVE	GA71105	FDA UDI	Class I	Active
Genesis ACTIVE	GA23016	FDA UDI	Class II	Active
Prima	45292K	FDA UDI	Class II	Active
Prima	45158K	FDA UDI	Class II	Active
Prima	45425K	FDA UDI	Class II	Active
Renova Implant System	14001K	FDA UDI	Class II	Unknown
ExHex	TMAX9-7	FDA UDI	Class II	Unknown
Prima	45209K	FDA UDI	Class II	Active
Restore	R9192-40-15K	FDA UDI	Class I	Active
Prima	15220K	FDA UDI	Class II	Active
ExHex	DBBB3.5	FDA UDI	Class II	Unknown
Genesis	G21105	FDA UDI	Class II	Active
Z-Max	TS-Z-MAX-18	FDA UDI	Class II	Unknown
ExHex	TBN2	FDA UDI	Class II	Unknown
Prima	E20101	FDA UDI	Class I	Active
Prima	45250K	FDA UDI	Class II	Active
Restore Implant System	11019K	FDA UDI	Class II	Active
Ex Hex Implant System	MAX-7-11	FDA UDI	Class II	Unknown
Prima	45815K	FDA UDI	Class II	Unknown
Genesis	G71222	FDA UDI	Class II	Active
Tri-Nex Implant System	IA43-12D-16	FDA UDI	Class II	Unknown
Genesis	G71141	FDA UDI	Class II	Active
Prima	02-541901111K	FDA UDI	Class II	Active
Stage 1	S2506K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71544	FDA UDI	Class II	Active
Prima	45277K	FDA UDI	Class II	Active
Max	45358K	FDA UDI	Class II	Active
Restore	R9203-50-48K	FDA UDI	Class II	Active
Tri-Nex	MC-L-35-2	FDA UDI	Class II	Unknown
Max	15873K	FDA UDI	Class II	Active
Genesis ACTIVE	GA22019	FDA UDI	Class II	Active
Genesis	G71202	FDA UDI	Class II	Active
Genesis	G71232	FDA UDI	Class II	Active
Genesis Implant System	G21138	FDA UDI	Class II	Active
Stage-1	S1100-35-16K	FDA UDI	Class I	Active
Ex Hex Implant System	BAT 24D-10	FDA UDI	Class II	Unknown
Genesis	G21292	FDA UDI	Class I	Active
Prima Implant System	15627K	FDA UDI	Class II	Active
Restore	L2400-50-00K	FDA UDI	Class II	Active
Stage-1	S1100-42-16K	FDA UDI	Class I	Active
Ex Hex Implant System	IBT 10	FDA UDI	Class II	Unknown
Prima	15720K	FDA UDI	Class I	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