Is this your brand? Sign in to claim ownership.

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 40 of 42

Device	Model / Reference	Registries	Class	Status
Genesis ACTIVE	GA23014	FDA UDI	Class II	Active
Restore	R2503-60-02K	FDA UDI	Class II	Active
Genesis ACTIVE	GA51002	FDA UDI	Class I	Active
Prima Plus	15771K	FDA UDI	Class I	Active
ExHex	GSU9	FDA UDI	Class II	Unknown
Oct	ITS6-TC1	FDA UDI	Class II	Unknown
Ex Hex Implant System	ZYG-55-55N	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71569	FDA UDI	Class I	Active
Tri-Nex Implant System	IA-LH-35-16	FDA UDI	Class II	Unknown
Restore Implant System	TS3811-UK	FDA UDI	Class II	Active
Restore Implant System	11021K	FDA UDI	Class II	Active
Stage 1	S1800-00	FDA UDI	Class II	Active
Ex Hex Implant System	MAX-9-7	FDA UDI	Class II	Unknown
Tri-Nex	MCL-35-17D3	FDA UDI	Class II	Unknown
Restore	L2500-60-01K	FDA UDI	Class II	Active
Tri-Nex	HA-L-60-3	FDA UDI	Class II	Unknown
Restore Implant System	RS3815K	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 12D-11.5	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW4810-2K	FDA UDI	Class II	Active
Zest	45274K	FDA UDI	Class I	Active
Tri-Nex Implant System	TRI-MAX9-11	FDA UDI	Class II	Unknown
Tri-Nex	GC-NL-43	FDA UDI	Class II	Unknown
Restore Implant System	RS5011K	FDA UDI	Class II	Active
ExHex	HMCT7-4	FDA UDI	Class II	Unknown
ExHex	TSU2	FDA UDI	Class II	Unknown
Restore	R9291-40-04K	FDA UDI	Class II	Active
Stage 1 Implant System	RSW4812-3K	FDA UDI	Class II	Active
Restore	L1408-55K	FDA UDI	Class I	Active
Restore Implant System	RS5013K	FDA UDI	Class II	Active
Restore	13085K	FDA UDI	Class I	Active
Tri-Nex	HA-L-60-5	FDA UDI	Class II	Unknown
Restore Implant System	RS4013-UK	FDA UDI	Class II	Active
Restore	L2100-62-19K	FDA UDI	Class I	Active
Tri-Nex	HA-L-50W-3	FDA UDI	Class II	Unknown
Restore Implant System	TS3313K	FDA UDI	Class II	Active
Restore	L1104-30-15K	FDA UDI	Class I	Active
Oct	TT4.5	FDA UDI	Class II	Unknown
Stage-1	S1100-16-16K	FDA UDI	Class I	Active
Oct Implant System	ITT514	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSR4108-3K	FDA UDI	Class II	Active
Restore	L1101-30-10K	FDA UDI	Class I	Active
ExHex	AMC30D-4	FDA UDI	Class II	Unknown
Tri-Nex	MCN-L-50-2	FDA UDI	Class II	Unknown
ExHex	EPC-TN-50-1KT	FDA UDI	Class II	Unknown
Tri-Nex	MCN-L-50-1	FDA UDI	Class II	Unknown
ExHex	TBBB4	FDA UDI	Class II	Unknown
Stage-1	S1101-20-16K	FDA UDI	Class I	Active
Ex Hex Implant System	BAT 24D-13	FDA UDI	Class II	Unknown
PrimaSolo	15230K	FDA UDI	Class I	Active
Restore	L1809-34-01K	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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