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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 9 of 42

Device	Model / Reference	Registries	Class	Status
Stage 1 Implant System	RSR3310-2K	FDA UDI	Class II	Active
ExHex	WBN4	FDA UDI	Class II	Unknown
Prima Plus	15765K	FDA UDI	Class I	Active
Z-Max Implant System	Z-MAX8-9	FDA UDI	Class II	Unknown
Max	45357K	FDA UDI	Class II	Active
Stage 1	S2501-70-1K	FDA UDI	Class II	Active
Stage-1	S9100-2K	FDA UDI	Class I	Active
ExHex	ABBBMCZ1	FDA UDI	Class II	Unknown
Ex Hex Implant System	BBBT 24D-11.5	FDA UDI	Class II	Unknown
Prima Implant System	15707K	FDA UDI	Class II	Active
Genesis	G71536	FDA UDI	Class II	Active
ExHex	TBN3	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71025	FDA UDI	Class II	Active
Genesis ACTIVE	GA22020	FDA UDI	Class II	Active
Prima	L1702-01K	FDA UDI	Class I	Active
Restore	R9200-40-48K	FDA UDI	Class II	Active
Restore	L2308-50-04K	FDA UDI	Class II	Active
Prima Implant System	15710K	FDA UDI	Class II	Active
Genesis	G21291	FDA UDI	Class I	Active
Restore	R9606-50-04K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71560	FDA UDI	Class II	Active
Genesis	G71201	FDA UDI	Class II	Active
Genesis Implant System	G21139	FDA UDI	Class II	Active
Prima Plus	15788K	FDA UDI	Class I	Active
Prima Implant System	15637K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71587	FDA UDI	Class II	Active
Oct	TT3	FDA UDI	Class II	Unknown
Tri-Nex	PA-EL-35	FDA UDI	Class II	Unknown
Prima Implant System	15636K	FDA UDI	Class II	Active
Restore	ISS1118K	FDA UDI	Class I	Active
Genesis Implant System	G21053	FDA UDI	Class II	Unknown
Prima Implant System	15633K	FDA UDI	Class II	Active
Prima	45334K	FDA UDI	Class II	Active
ExHex	SC7	FDA UDI	Class II	Unknown
Prima	15282K	FDA UDI	Class I	Active
Stage 1	S2400K	FDA UDI	Class II	Active
ExHex	TBA4	FDA UDI	Class II	Unknown
Oct Implant System	MAXIT8-7	FDA UDI	Class II	Unknown
Renova	43090K	FDA UDI	Class II	Unknown
ExHex	ABNMC5	FDA UDI	Class II	Unknown
ExHex	EPC-EX-40-2KT	FDA UDI	Class II	Unknown
Prima	15252K	FDA UDI	Class I	Active
ExHex	WBN3	FDA UDI	Class II	Unknown
Tri-Nex Implant System	IA-LH-50-10	FDA UDI	Class II	Unknown
Genesis	G71466	FDA UDI	Class II	Active
Genesis ACTIVE	GA71579	FDA UDI	Class II	Active
Oct	TSAF5.5	FDA UDI	Class II	Unknown
ExHex	WBBB2	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71024	FDA UDI	Class II	Active
Genesis	G71514	FDA UDI	Class II	Active

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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