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 6 of 42

Device	Model / Reference	Registries	Class	Status
Genesis	G71216	FDA UDI	Class II	Active
Restore	R9290-40-04K	FDA UDI	Class II	Active
Restore	L1300-20-30K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71533	FDA UDI	Class I	Active
Stage-1	S1803-55K	FDA UDI	Class I	Active
Genesis	G21011	FDA UDI	Class I	Active
Stage 1	S2435K	FDA UDI	Class II	Active
Genesis	G71447	FDA UDI	Class II	Active
Restore	L1100-52-15K	FDA UDI	Class I	Active
Restore	R9192-50-15K	FDA UDI	Class I	Active
Oct Implant System	ITC514	FDA UDI	Class II	Unknown
Genesis	G71613	FDA UDI	Class I	Active
Restore	R9291-50-02K	FDA UDI	Class II	Active
Renova Implant System	13009K	FDA UDI	Class II	Unknown
Restore	R9291-34-02K	FDA UDI	Class II	Active
Prima Plus	15787K	FDA UDI	Class I	Active
Restore	L1101-20-10K	FDA UDI	Class I	Active
Stage 1 Implant System	RSW5510-3K	FDA UDI	Class II	Active
Restore	L2100-35-19K	FDA UDI	Class I	Active
Restore	L1400-35-23K	FDA UDI	Class I	Active
Genesis ACTIVE	GA22014	FDA UDI	Class II	Active
Stage-1	S2440-01K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23013	FDA UDI	Class II	Active
Genesis ACTIVE	GA71547	FDA UDI	Class II	Active
Tri-Nex	TCA12-EL-60	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15111	FDA UDI	Class I	Active
Prima	001-0787-00	FDA UDI	Class II	Active
Prima	15319K	FDA UDI	Class II	Active
Tri-Nex	TCA12-EL-35	FDA UDI	Class II	Unknown
Prima Plus	15728K	FDA UDI	Class I	Active
Genesis	G71210	FDA UDI	Class II	Active
Genesis ACTIVE	GA22007	FDA UDI	Class II	Active
Prima	15237K	FDA UDI	Class I	Active
Restore	41005K	FDA UDI	Class II	Active
ExHex	TBA6	FDA UDI	Class II	Unknown
Prima	15671K	FDA UDI	Class I	Active
Tri-Nex	TMCW1	FDA UDI	Class II	Unknown
Ex Hex Implant System	ZYG-55-47.5N	FDA UDI	Class II	Unknown
Tri-Nex	TC-NL-60-1	FDA UDI	Class II	Unknown
ExHex	AMCZ2	FDA UDI	Class II	Unknown
Restore	R9210-50-01K	FDA UDI	Class II	Active
Restore	L1101-33-20K	FDA UDI	Class I	Active
Restore	L1700-72K	FDA UDI	Class I	Active
ExHex	WBBB6	FDA UDI	Class II	Unknown
Oct	TT6-2	FDA UDI	Class II	Unknown
Stage 1	S1806-45K	FDA UDI	Class II	Active
PrimaSolo	15228K	FDA UDI	Class I	Active
Restore	L1805-20-15K	FDA UDI	Class I	Active
Tri-Nex	TCA12-EL-50	FDA UDI	Class II	Unknown
Stage 1	42004K	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