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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 7 of 42

Device	Model / Reference	Registries	Class	Status
Oct	SYN20D-C6	FDA UDI	Class II	Unknown
Genesis Implant System	G21146	FDA UDI	Class II	Active
Tri-Nex	GC-NL-35	FDA UDI	Class II	Unknown
Tri-Nex	HA-L-35W-3	FDA UDI	Class II	Unknown
Oct	ITS-GC1NE	FDA UDI	Class II	Unknown
Restore	ISS1119K	FDA UDI	Class I	Active
Genesis ACTIVE	G15106	FDA UDI	Class I	Active
Genesis	45810K	FDA UDI	Class II	Active
Prima	45289K	FDA UDI	Class II	Active
Prima	15721K	FDA UDI	Class I	Active
Tri-Nex	TCA24-EL-35	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71612	FDA UDI	Class II	Active
Restore	L1100-16-15K	FDA UDI	Class I	Active
Genesis ACTIVE	GA22010	FDA UDI	Class II	Active
Genesis	45957K	FDA UDI	Class I	Active
Stage-1	S1701-01K	FDA UDI	Class I	Active
Prima	45261K	FDA UDI	Class II	Active
Prima	45422K	FDA UDI	Class II	Active
Restore	L1413-01K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71532	FDA UDI	Class I	Active
Tri-Nex	HA-L-43-5	FDA UDI	Class II	Unknown
ExHex	EPC-TN-60-3KT	FDA UDI	Class II	Unknown
Restore	L1400-62-19K	FDA UDI	Class I	Active
Genesis	G21009	FDA UDI	Class I	Active
Prima	45323K	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 12D-10	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71592	FDA UDI	Class I	Active
Prima	15202K	FDA UDI	Class I	Active
Genesis	G71440	FDA UDI	Class II	Active
Oct	P-CAP6-55	FDA UDI	Class II	Unknown
Restore Implant System	RS5013-UK	FDA UDI	Class II	Active
Restore	L1810-40-01K	FDA UDI	Class II	Active
Stage 1 Implant System	RSW5512-3K	FDA UDI	Class II	Active
Genesis	G71511	FDA UDI	Class II	Active
Genesis	G31020	FDA UDI	Class I	Active
Stage 1 Implant System	RSR4110-2K	FDA UDI	Class II	Active
Oct	SYN20D-F6	FDA UDI	Class II	Unknown
Prima	45050K	FDA UDI	Class II	Active
ExHex	ABBBMC1	FDA UDI	Class II	Unknown
Genesis	G31008	FDA UDI	Class I	Active
Stage-1	S1100-20-16K	FDA UDI	Class I	Active
Genesis	G31035	FDA UDI	Class I	Active
Genesis ACTIVE	G15112	FDA UDI	Class I	Active
Prima	15302K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71030	FDA UDI	Class II	Active
Genesis ACTIVE	GA71591	FDA UDI	Class I	Active
Stage-1	ISS141K	FDA UDI	Class I	Active
Prima	15066K	FDA UDI	Class I	Active
Stage 1	S2417-2K	FDA UDI	Class II	Active
Genesis ACTIVE	GA22015	FDA UDI	Class II	Active

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Importers

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Notified Bodies

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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