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 25 of 42

Device	Model / Reference	Registries	Class	Status
Tri-Nex Implant System	IA-LH-43-11.5	FDA UDI	Class II	Unknown
Genesis	G31024	FDA UDI	Class I	Active
Prima Implant System	15615K	FDA UDI	Class II	Active
Prima	15303K	FDA UDI	Class II	Active
Tri-Nex Implant System	IA-LH-50-8	FDA UDI	Class II	Unknown
Prima	15222K	FDA UDI	Class II	Active
Restore	L1104-20-10K	FDA UDI	Class I	Active
Ex Hex Implant System	BBBS 11.5	FDA UDI	Class II	Unknown
ExHex	GSQ3	FDA UDI	Class II	Unknown
Tri-Nex	GC-EL-35	FDA UDI	Class II	Unknown
Ex Hex Implant System	BA 13	FDA UDI	Class II	Unknown
Restore	L2304-42-03K	FDA UDI	Class II	Active
Genesis	G71206	FDA UDI	Class II	Active
Restore	41003K	FDA UDI	Class II	Active
Prima	15679K	FDA UDI	Class I	Active
Restore	41002K	FDA UDI	Class II	Active
Stage 1	S1806-30K	FDA UDI	Class II	Active
Oct Implant System	ITC306	FDA UDI	Class II	Unknown
Genesis	G71442	FDA UDI	Class II	Active
Prima	15064K	FDA UDI	Class I	Active
Prima	15225K	FDA UDI	Class I	Active
Prima	15304K	FDA UDI	Class II	Active
Prima Plus	15774K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23007	FDA UDI	Class II	Active
Prima	45293K	FDA UDI	Class I	Active
Prima	15675K	FDA UDI	Class I	Active
Restore Implant System	RS3315K	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 8.5	FDA UDI	Class II	Unknown
Restore Implant System	TS4011K	FDA UDI	Class II	Active
ExHex	AMC17D-3	FDA UDI	Class II	Unknown
Genesis	G21276	FDA UDI	Class I	Active
Prima	15308K	FDA UDI	Class II	Active
Prima	15665K	FDA UDI	Class I	Active
Ex Hex Implant System	IBS 10	FDA UDI	Class II	Unknown
Genesis	G21244	FDA UDI	Class I	Active
Genesis	G31045	FDA UDI	Class I	Active
Restore	R9633-50-06K	FDA UDI	Class II	Active
Renova Implant System	13006K	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBS 15	FDA UDI	Class II	Unknown
Sustain	410605-3-5K	FDA UDI	Class II	Active
Stage-1	S1402-01K	FDA UDI	Class I	Active
Restore	L2402-50-03K	FDA UDI	Class II	Active
DynaGraft D	10.110.1050	FDA UDI	Class II	Active
Stage-1	S1100-28-16K	FDA UDI	Class I	Active
Prima	45263K	FDA UDI	Class II	Active
Genesis	G21290	FDA UDI	Class I	Active
Prima	45421K	FDA UDI	Class II	Active
Genesis ACTIVE	G15101	FDA UDI	Class I	Active
Genesis ACTIVE	GA21015	FDA UDI	Class II	Active
Prima Implant System	15618K	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