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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 31 of 42

Device	Model / Reference	Registries	Class	Status
ExHex	WB6	FDA UDI	Class II	Unknown
Prima	15209K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71620	FDA UDI	Class II	Active
Renova	43104K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71012	FDA UDI	Class I	Active
Genesis ACTIVE	GA71607	FDA UDI	Class II	Active
Genesis ACTIVE	GA71526	FDA UDI	Class I	Active
Restore	L1101-28-10K	FDA UDI	Class I	Active
Oct Implant System	MAXIT8-9	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71618	FDA UDI	Class II	Active
Genesis	G21106	FDA UDI	Class II	Active
Restore	L1806-04K	FDA UDI	Class I	Active
ExHex	EPC-TN-35-3KT	FDA UDI	Class II	Unknown
ExHex	DB3.5	FDA UDI	Class II	Unknown
Restore	L1101-33-10K	FDA UDI	Class I	Active
Tri-Nex	TC-EL-35-1	FDA UDI	Class II	Unknown
Prima	45000K	FDA UDI	Class II	Active
Genesis	G71219	FDA UDI	Class II	Active
Genesis	G71138	FDA UDI	Class II	Active
Genesis	G71149	FDA UDI	Class II	Active
ExHex	ABBBMCZ3	FDA UDI	Class II	Unknown
Restore	L1406-02K	FDA UDI	Class I	Active
Prima	45807K	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBT 13	FDA UDI	Class II	Unknown
Restore	R9290-40-02K	FDA UDI	Class II	Active
Genesis ACTIVE	G71710	FDA UDI	Class I	Active
Prima Plus	15773K	FDA UDI	Class I	Active
Prima	ISS1111K	FDA UDI	Class I	Active
Stage 1 Implant System	RSR3308-2K	FDA UDI	Class II	Active
Genesis ACTIVE	GA51003	FDA UDI	Class I	Active
Genesis	G21112	FDA UDI	Class II	Active
Genesis	G71609	FDA UDI	Class I	Active
Restore	L1400-48-23K	FDA UDI	Class I	Active
Stage 1 Implant System	RSR4114-3K	FDA UDI	Class II	Active
Restore	R9122K	FDA UDI	Class I	Active
Prima Plus	15759K	FDA UDI	Class I	Active
Restore	R9303-50-48K	FDA UDI	Class II	Active
Genesis	G21275	FDA UDI	Class I	Active
Restore	R9291-50-04K	FDA UDI	Class II	Active
Restore	L2300-33-03K	FDA UDI	Class II	Active
ExHex	DN2	FDA UDI	Class II	Unknown
Z-Max Implant System	Z-MAX8-11	FDA UDI	Class II	Unknown
Tri-Nex Implant System	TRI-MAX8-7	FDA UDI	Class II	Unknown
Genesis	45809K	FDA UDI	Class II	Active
Prima	45431K	FDA UDI	Class II	Active
Prima Implant System	15431K	FDA UDI	Class II	Active
ExHex	ABAMC1	FDA UDI	Class II	Unknown
Renova	10037K	FDA UDI	Class II	Unknown
Genesis	G21107	FDA UDI	Class II	Active
Genesis ACTIVE	GA71033	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