Question 1

What types of medical devices does Lynch BioLogics, LLC manufacture?

Accepted Answer

Lynch BioLogics, LLC specializes in periodontal root surface regeneration materials. These devices are specifically designed to aid in tissue regeneration and healing during dental procedures, such as periodontal treatments. Their primary focus is on products that promote bone and tissue growth in the oral cavity.

Question 2

Where is Lynch BioLogics, LLC based?

Accepted Answer

Lynch BioLogics, LLC is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

Question 3

Which regulatory registries or databases list Lynch BioLogics, LLC’s devices?

Accepted Answer

Lynch BioLogics, LLC’s devices are listed in the FDA’s Premarket Approval (PMA) registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure traceability and compliance tracking for Class III devices, which require rigorous pre-market authorization.

Question 4

How are Lynch BioLogics, LLC’s devices classified under FDA regulations?

Accepted Answer

Lynch BioLogics, LLC’s devices fall under Class III classification by the FDA. This classification applies to products that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require Premarket Approval (PMA) due to their higher risk profile.

Device	Model / Reference	Registries	Class	Status
GEM™ Bone Graft	LBNB4010	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNB1020	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNB1010	FDA UDI	Class II	Unknown
GEM™ Synthetic Bone Graft	LBSB050	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNB2020	FDA UDI	Class II	Unknown
GEM™ Wound Dressing Foam	LBWDF	FDA UDI	U	Unknown
Gem 21s®	LBGEM05	FDA UDI	Class III	Active
GEM Adapt™	LBADAPT3040	FDA UDI	Class II	Unknown
GEM™ Wound Dressing Plug	LBWDP	FDA UDI	U	Unknown
GEM™ Synthetic Bone Graft	LBSB100	FDA UDI	Class II	Unknown
GEM Extend™	LBEXT1520	FDA UDI	Class II	Unknown
GEM Adapt™	LBADAPT1520	FDA UDI	Class II	Unknown
GEM™ Wound Dressing Tape	LBWDT	FDA UDI	U	Unknown
GEM™ Synthetic Bone Graft	LBSB200	FDA UDI	Class II	Unknown
GEM Extend™	LBEXT2030	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNBS025	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNBS05	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNB2010	FDA UDI	Class II	Unknown
GEM™ Bone Graft	LBNB0510	FDA UDI	Class II	Unknown
GEM Adapt™	LBADAPT2030	FDA UDI	Class II	Unknown
GEM Cap™	LBCAP1216	FDA UDI	Class II	Unknown
GEM Extend™	LBEXT3040	FDA UDI	Class II	Unknown
Gem 21s Growth Factor Enhance Matrix	P040013	FDA PMA	Class III	Active

LYNCH BIOLOGICS, LLC

What LYNCH BIOLOGICS, LLC makes

Frequently asked questions

Information

Catalogue (23)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities