KEYSTONE DENTAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005990499	3005990499	KEYSTONE DENTAL, INC.	1	N	2020-04-25	154 Middlesex Turnpike BURLINGTON MA US 01803

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
D76802538901111K0	Prima - Gold UCLA Abutment	+1(866)902-9272	info@keystonedental.com
D76802541901111K0	Prima - Gold UCLA Abutment	+1(866)902-9272	info@keystonedental.com
D76802550901111K0	Prima - Healing Abutment	+1(866)902-9272	info@keystonedental.com

keystonedental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
67787	1332945212	K994205	MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM	DZE	2000-02-29
67787	1244013934	K993894	LIFECORE SINGLE TOOTH ABUTMENT SYSTEM	DZE	2000-03-08
67787	1350762162	K991114	REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM	DZE	1999-07-14
67787	1998052813	K970776	LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT	DZE	1997-05-27
67787	1452523882	K960288	HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM	DZE	1996-03-28
67787	1547102074	K954865	RESTORE HA DENTAL IMPLANT SYSTEM	DZE	1996-01-11
67787	1641599104	K954819	RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM	DZE	1996-01-11
67787	1029290355	K954512	RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM	DZE	1996-02-23
67787	1209402875	K951111	RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)	DZE	1995-03-31
67787	1320277192	K950624	HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM	DZE	1995-08-30
67787	1738046667	K944069	RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM	DZE	1995-02-28
67787	1183083181	K944068	RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)	DZE	1995-02-02
67787	1300152169	K941554	SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM	DZE	1994-07-22
67787	1743680179	K931468	RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM	DZE	1994-07-12
67787	1733136226	K914137	HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS	DZE	1994-02-03
67787	1587193349	K101545	GENESIS IMPLANT SYSTEM	DZE	2010-10-28
67787	1204097852	K093562	ENDOSSEOUS DENTAL IMPLANT	DZE	2010-10-14
67787	1514797364	K082651	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	2008-12-22
67787	1638648530	K073032	PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS	NHA	2007-11-16
67787	1933553622	K072768	RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS	DZE	2007-10-23
67787	1564641584	K072572	PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS	NHA	2007-10-05
67787	1862140523	K072241	PRIMACONNEX CAD/CAM ABUTMENT SYSTEM	NHA	2007-11-09
67787	1755945682	K071161	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	2007-11-16
67787	1607717513	K070905	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	2007-05-24
67787	1671061476	K070841	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	2007-06-21
67787	1386067706	K062876	PRIMACONNEX CERAMIC ABUTMENTS	NHA	2006-11-01
67787	1286253233	K061169	ENDOSSEOUS DENTAL IMPLANT	DZE	2006-06-20
67787	1064378058	K060530	SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.	ELL	2006-05-22
67787	1935351474	K060332	ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY	NUN	2006-03-29
67787	1133850741	K060306	ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY	NUN	2006-03-27
67787	1237643362	K053643	STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026	NHA	2006-01-23
67787	1313138201	K052490	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	2005-12-08
67787	1446930736	K051614	PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS	DZE	2005-09-09
67787	1450682574	K050506	PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS	DZE	2005-04-15
67787	1296638710	K043573	DYNAGRAFT II DENTAL	NUN	2005-07-29
67787	1352300493	K042730	CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G	LYC	2005-02-14
67787	2059731994	K041324	CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER	LYC	2004-07-19
67787	1579845150	K033171	NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING	DZE	2004-04-27
67787	1647312752	K032495	THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM	DZE	2003-09-17
67787	1047263775	K020617	NSI HEXED AND NON-HEXED IMPLANT SYSTEM	DZE	2002-05-10
67787	1619824485	K003620	NSI HEXED AND NON-HEXED IMPLANT SYSTEM	DZE	2001-09-19
67787	1592918012	K003226	THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM	DZE	2001-01-12
67787	1064207902	K002037	LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS	DZE	2001-05-16
67787	1040809439
67787	1224459103
67787	1227113896
67787	1325563676
67787	1394489041
67787	1481781869
67787	1704126751
67787	1805196591
67787	1903424121

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DZE	32	2010-10-28
NHA	5	2007-11-16
NUN	3	2006-03-29
LYC	2	2005-02-14
ELL	1	2006-05-22

PMN#

Prima Plus Conical Implant System
2024-07-09
Keystone Dental, Inc.
Genesis ACTIVE Implant System
2023-05-25
Keystone Dental, Inc.
Keystone Dental XL Dental Implant System
2020-08-18
Keystone Dental, Inc.
XPI ANGLED ABUTMENTS
2009-06-05
Keystone Dental, Inc.
OLYMPUS DENTAL IMPLANT SYSTEM
2007-10-23
KEYSTONE DENTAL, INC.
EASYGUIDE
2007-07-11
KEYSTONE DENTAL, INC.

GUDID#

Prima - Gold UCLA Abutment
KEYSTONE DENTAL, INC.
2017-12-13
Prima - Gold UCLA Abutment
KEYSTONE DENTAL, INC.
2017-12-13
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2017-12-13
Prima - Cover Screw
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Cover Screw
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Cover Screw
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima - Healing Abutment
KEYSTONE DENTAL, INC.
2016-02-04
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29
Prima Implant System - Implant
KEYSTONE DENTAL, INC.
2016-01-29

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