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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 41 of 42

Device	Model / Reference	Registries	Class	Status
Stage-1	S1802K	FDA UDI	Class I	Active
Renova Implant System	14000K	FDA UDI	Class II	Unknown
Tri-Nex Implant System	TRI-MAX9-7	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW5510-2K	FDA UDI	Class II	Active
Tri-Nex	HA-L-35W-5	FDA UDI	Class II	Unknown
Oct	ITS6-PA	FDA UDI	Class II	Unknown
DynaBlast	10.220.1050	FDA UDI	Class II	Active
Restore	L1400-80-23K	FDA UDI	Class I	Active
Tri-Nex	MCL-35-17D2	FDA UDI	Class II	Unknown
Renova	10035K	FDA UDI	Class II	Unknown
Oct	ITS-TC1NE	FDA UDI	Class II	Unknown
Restore Implant System	TS3810K	FDA UDI	Class II	Active
Oct	ITS-GC1	FDA UDI	Class II	Unknown
ExHex	WBA2	FDA UDI	Class II	Unknown
Stage-1	S1501-48-10K	FDA UDI	Class I	Active
Restore	L2300-33-01K	FDA UDI	Class II	Active
Ex Hex Implant System	MAX-7-9	FDA UDI	Class II	Unknown
Tri-Nex	MCL-43-17D4	FDA UDI	Class II	Unknown
Tri-Nex Implant System	IA-LH-60-10	FDA UDI	Class II	Unknown
Accell Connexus	10.310.1050	FDA UDI	Class II	Active
Stage-1	S1701-02K	FDA UDI	Class I	Active
Tri-Nex	TC-NL-35-1	FDA UDI	Class II	Unknown
Restore	R9633-34-04K	FDA UDI	Class II	Active
Accell Connexus	10.310.1080	FDA UDI	Class II	Active
ExHex	TBBB3	FDA UDI	Class II	Unknown
Tri-Nex	TC-EL-50-1	FDA UDI	Class II	Unknown
ExHex	P-CAP-40	FDA UDI	Class II	Unknown
Oct Implant System	MAXIT7-9	FDA UDI	Class II	Unknown
Restore	L2807-01K	FDA UDI	Class II	Unknown
ExHex	TCB1H	FDA UDI	Class II	Unknown
Stage-1	S1101-35-16K	FDA UDI	Class I	Active
ExHex	GC-EX-70	FDA UDI	Class II	Unknown
Restore	R2800-00K	FDA UDI	Class II	Active
Ex Hex Implant System	ZYG-55-37.5N	FDA UDI	Class II	Unknown
Ex Hex Implant System	BAT 11.5	FDA UDI	Class II	Unknown
Restore	11028K	FDA UDI	Class I	Active
Restore	R9284-40K	FDA UDI	Class II	Active
Sustain	410720-4K	FDA UDI	Class II	Active
Tri-Nex	PA-NL-60	FDA UDI	Class II	Unknown
Stage 1	42017K	FDA UDI	Class II	Active
Restore	L1504-60-15K	FDA UDI	Class I	Active
Tri-Nex Implant System	IA-LH-43-8	FDA UDI	Class II	Unknown
Restore Implant System	RS3310-UK	FDA UDI	Class II	Active
Restore	R9650-40-03K	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4110-3K	FDA UDI	Class II	Active
Renova Implant System	14004K	FDA UDI	Class II	Unknown
Stage-1	S1100-48-16K	FDA UDI	Class I	Active
Restore	L1300-42-50K	FDA UDI	Class I	Active
ExHex	ABAMC5.5	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW4810-3K	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