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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 13 of 42

Device	Model / Reference	Registries	Class	Status
Prima	45966K	FDA UDI	Class II	Active
Sustain	410240-34-04K	FDA UDI	Class II	Active
Renova	43107K	FDA UDI	Class II	Unknown
ExHex	TBBB2	FDA UDI	Class II	Unknown
Max	15880K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71053	FDA UDI	Class II	Active
Max	45962K	FDA UDI	Class II	Active
Prima	45302K	FDA UDI	Class II	Active
Genesis	G21008	FDA UDI	Class I	Active
Genesis ACTIVE	GA71635	FDA UDI	Class II	Active
Genesis	G21103	FDA UDI	Class II	Active
Tri-Nex	PA-MC-48	FDA UDI	Class II	Unknown
Restore	L1100-28-15K	FDA UDI	Class I	Active
Tri-Nex Implant System	TRI-MAX7-9	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBT 12D-11.5	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71571	FDA UDI	Class II	Active
Prima	45330K	FDA UDI	Class II	Active
ExHex	SMAX9NH	FDA UDI	Class II	Unknown
ExHex	DBBBS24	FDA UDI	Class II	Unknown
Restore Implant System	TS4013K	FDA UDI	Class II	Active
Genesis	G71463	FDA UDI	Class II	Active
Genesis	G71612	FDA UDI	Class I	Active
Tri-Nex	GC-EL-60	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71040	FDA UDI	Class II	Active
Ex Hex Implant System	MAX-9-9	FDA UDI	Class II	Unknown
Prima	15259K	FDA UDI	Class I	Active
Genesis	G71215	FDA UDI	Class II	Active
Ex Hex Implant System	IBS 7	FDA UDI	Class II	Unknown
ExHex	GC-EX-60	FDA UDI	Class II	Unknown
Restore Implant System	11012K	FDA UDI	Class II	Active
Oct	TT0	FDA UDI	Class II	Unknown
Restore	L1300-42-52K	FDA UDI	Class I	Active
Tri-Nex	TCA24-EL-50	FDA UDI	Class II	Unknown
Prima	45154K	FDA UDI	Class II	Active
DynaGraft D	10.110.1060	FDA UDI	Class II	Active
PrimaSolo	15227K	FDA UDI	Class I	Active
Tri-Nex Implant System	IA50-12D-10	FDA UDI	Class II	Unknown
ExHex	DBNS12	FDA UDI	Class II	Unknown
Prima	45314K	FDA UDI	Class II	Active
Prima	15075K	FDA UDI	Class I	Active
Restore Implant System	TS4015K	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4814-2K	FDA UDI	Class II	Active
Renova	43094K	FDA UDI	Class II	Unknown
Tri-Nex	CS-L-35	FDA UDI	Class II	Unknown
Restore	L1400-35-28K	FDA UDI	Class I	Active
Restore	R9210-50-03K	FDA UDI	Class II	Active
Restore	R9633-50-02K	FDA UDI	Class II	Active
Restore	L2405-50-00K	FDA UDI	Class II	Active
Prima Implant System	15416K	FDA UDI	Class II	Active
Restore	R9290-50-04K	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