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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 2 of 42

Device	Model / Reference	Registries	Class	Status
Prima	45063K	FDA UDI	Class II	Active
Restore Implant System	TS5010K	FDA UDI	Class II	Active
Genesis Implant System	G21140	FDA UDI	Class II	Active
Tri-Nex	HA-L-35-5	FDA UDI	Class II	Unknown
Restore	L2100-85-19K	FDA UDI	Class I	Active
Restore	L1101-20-15K	FDA UDI	Class I	Active
Prima	001-0945-00	FDA UDI	Class II	Active
Oct Implant System	ITT612	FDA UDI	Class II	Unknown
ExHex	TBN6	FDA UDI	Class II	Unknown
Restore	L1502-60-15K	FDA UDI	Class I	Active
Restore	L1502-33-13K	FDA UDI	Class I	Active
Z-Max Implant System	Z-MAX8-7	FDA UDI	Class II	Unknown
Prima	45002K	FDA UDI	Class II	Active
Restore	L1502-40-18K	FDA UDI	Class I	Active
ExHex	TSU1	FDA UDI	Class II	Unknown
Prima	15251K	FDA UDI	Class I	Active
Genesis Implant System	G21153	FDA UDI	Class II	Active
Stage 1	S2432-55-1K	FDA UDI	Class II	Active
DynaBlast	10.210.1060	FDA UDI	Class II	Active
Genesis ACTIVE	GA21009	FDA UDI	Class II	Active
Prima	45442K	FDA UDI	Class II	Active
ExHex	DB5	FDA UDI	Class II	Unknown
Prima	15287K	FDA UDI	Class I	Active
Genesis ACTIVE	GA22005	FDA UDI	Class II	Active
Genesis	G31028	FDA UDI	Class I	Active
Ex Hex Implant System	IBT 12D-15	FDA UDI	Class II	Unknown
ExHex	ABAMCZ5	FDA UDI	Class II	Unknown
Restore	R9304-40-48K	FDA UDI	Class II	Active
Prima Plus	15767K	FDA UDI	Class I	Active
Restore	41000K	FDA UDI	Class II	Active
Tri-Nex	CS-L-50	FDA UDI	Class II	Unknown
ExHex	TBBB6	FDA UDI	Class II	Unknown
Oct	SYN615D-C6	FDA UDI	Class II	Unknown
Stage-1	S2428K	FDA UDI	Class I	Active
ExHex	HMCW4	FDA UDI	Class II	Unknown
Oct	TT6-3	FDA UDI	Class II	Unknown
Restore	L2800-02K	FDA UDI	Class I	Active
Genesis	G71445	FDA UDI	Class II	Active
Restore	R9642-34-02K	FDA UDI	Class II	Active
Sustain	410200-47-30K	FDA UDI	Class II	Active
Restore	L1401-38-01K	FDA UDI	Class I	Active
Restore	L1100-33-10K	FDA UDI	Class I	Active
Genesis	G21279	FDA UDI	Class I	Active
Prima Plus	15785K	FDA UDI	Class I	Active
Prima	E40100	FDA UDI	Class I	Active
Stage-1	S9101-1K	FDA UDI	Class I	Active
Stage-1	S2441-01K	FDA UDI	Class I	Active
Restore	R9135-30-15K	FDA UDI	Class I	Active
Genesis	G71200	FDA UDI	Class II	Active
ExHex	ABAMC30D-4	FDA UDI	Class II	Unknown

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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