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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 10 of 42

Device	Model / Reference	Registries	Class	Status
Restore	R9185-33K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71036	FDA UDI	Class II	Active
ExHex	TBN4	FDA UDI	Class II	Unknown
ExHex	HMCW6	FDA UDI	Class II	Unknown
Genesis	G71214	FDA UDI	Class II	Active
Prima	15664K	FDA UDI	Class I	Active
Prima Implant System	15403K	FDA UDI	Class II	Active
Prima	15322K	FDA UDI	Class II	Active
Genesis	G71221	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 24D-10	FDA UDI	Class II	Unknown
Genesis	G71608	FDA UDI	Class I	Active
Tri-Nex	MC-L-43-2	FDA UDI	Class II	Unknown
Tri-Nex	MC-L-35-1	FDA UDI	Class II	Unknown
Prima Plus	15772K	FDA UDI	Class I	Active
Ex Hex Implant System	MAX-8-7	FDA UDI	Class II	Unknown
Prima	15307K	FDA UDI	Class II	Active
ExHex	EPC-TN-50-3KT	FDA UDI	Class II	Unknown
Renova	43006K	FDA UDI	Class II	Unknown
Restore	L1803-01K	FDA UDI	Class I	Active
Prima	15101K	FDA UDI	Class I	Active
Restore Implant System	RS3815-UK	FDA UDI	Class II	Active
Stage 1 Implant System	RSR3312-3K	FDA UDI	Class II	Active
Genesis	G71145	FDA UDI	Class II	Active
Restore	L1805-20-25K	FDA UDI	Class I	Active
Restore	L2402-50-02K	FDA UDI	Class II	Active
ExHex	WB3	FDA UDI	Class II	Unknown
Prima	45284K	FDA UDI	Class II	Active
Max	15881K	FDA UDI	Class II	Active
Genesis	G71437	FDA UDI	Class II	Active
Tri-Nex	PA-NL-43	FDA UDI	Class II	Unknown
Restore	L1101-30-20K	FDA UDI	Class I	Active
ExHex	EPC-TN-43-2KT	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71566	FDA UDI	Class I	Active
Restore	L1800-22-02K	FDA UDI	Class I	Active
Prima	001-0788-00	FDA UDI	Class II	Active
Restore	L1409-60K	FDA UDI	Class I	Active
Tri-Nex	MC-L-43-3	FDA UDI	Class II	Unknown
ExHex	TSH1	FDA UDI	Class II	Unknown
Restore Implant System	RS4008K	FDA UDI	Class II	Active
ExHex	TSU9	FDA UDI	Class II	Unknown
Tri-Nex	HA-L-60W-3	FDA UDI	Class II	Unknown
Genesis	G31039	FDA UDI	Class I	Active
Genesis	45812K	FDA UDI	Class II	Active
Genesis	G31017	FDA UDI	Class I	Active
Restore	L1100-28-20K	FDA UDI	Class I	Active
Genesis ACTIVE	GA21017	FDA UDI	Class II	Active
Prima Implant System	15708K	FDA UDI	Class II	Active
Prima	15218K	FDA UDI	Class I	Active
Prima	45427K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71609	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