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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 15 of 42

Device	Model / Reference	Registries	Class	Status
Prima	45153K	FDA UDI	Class II	Active
Prima	40007K	FDA UDI	Class I	Active
Restore Implant System	11009K	FDA UDI	Class II	Active
Restore	L2402-50-04K	FDA UDI	Class II	Active
Prima	45066K	FDA UDI	Class II	Active
Prima	15290K	FDA UDI	Class I	Active
PrimaSolo	15242K	FDA UDI	Class I	Active
ExHex	DBAS12	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSR3314-2K	FDA UDI	Class II	Active
Z-Max Implant System	Z-MAX9-7	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBT 11.5	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA23004	FDA UDI	Class II	Active
Restore	L1502-60-13K	FDA UDI	Class I	Active
Prima	45255K	FDA UDI	Class II	Active
Restore	R9633-40-04K	FDA UDI	Class II	Active
Genesis ACTIVE	GA21016	FDA UDI	Class II	Active
Restore	L1400-85-28K	FDA UDI	Class I	Active
Prima	001-0789-00	FDA UDI	Class II	Active
Tri-Nex	PA-NL-35P	FDA UDI	Class II	Unknown
Restore	L2307-42-01K	FDA UDI	Class II	Active
Renova	43092K	FDA UDI	Class II	Unknown
Prima	15074K	FDA UDI	Class I	Active
ExHex	DBA2	FDA UDI	Class II	Unknown
Prima Plus	15786K	FDA UDI	Class I	Active
Renova Implant System	14005K	FDA UDI	Class II	Unknown
ExHex	GC-NX-40	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15147	FDA UDI	Class I	Active
Oct Implant System	ITC412	FDA UDI	Class II	Unknown
Genesis	G71235	FDA UDI	Class II	Active
Restore	R9650-40-04K	FDA UDI	Class II	Active
Renova	43010K	FDA UDI	Class II	Unknown
Ex Hex Implant System	BBBT 12D-13	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA31001	FDA UDI	Class I	Active
Genesis	G71502	FDA UDI	Class II	Active
Accell Connexus	10.310.1070	FDA UDI	Class II	Active
Restore	L1410-60K	FDA UDI	Class I	Active
Genesis	G71125	FDA UDI	Class II	Active
Restore	R9606-50-06K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71577	FDA UDI	Class II	Active
Stage-1	S1101-48-10K	FDA UDI	Class I	Active
Renova	10039K	FDA UDI	Class II	Unknown
Restore Implant System	RS3311-UK	FDA UDI	Class II	Active
Genesis ACTIVE	GA71011	FDA UDI	Class I	Active
Prima	45039K	FDA UDI	Class II	Active
Genesis ACTIVE	GA21013	FDA UDI	Class II	Active
Prima	15741K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71589	FDA UDI	Class II	Active
Tri-Nex	TC-NL-43-1	FDA UDI	Class II	Unknown
Genesis	G31027	FDA UDI	Class I	Active
Genesis ACTIVE	GA71539	FDA UDI	Class II	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